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Huibregtse K. Biliary endoprostheses in elderly patients with transcystic duct balloon dilatation of the sphincter of Oddi. Surg
endoscopically irretrievable common bile duct stones: report on 117 Endosc 1993; 7: 514–17.
patients. Gastrointest Endosc 1995; 42: 195–201. 24 Nelson DB, Freeman ML. Major hemorrhage from endoscopic
19 Staritz M, Poralla T, Klose K, Meyer zum Buschenfelde KH. sphincterotomy: risk factor analysis. J Clin Gastroenterol 1994; 19:
Magnification of the endoscope during endoscopic retrograde 283–87.
cholangiography—a reliable standard for exact measurement of
25 Maki T. Pathogenesis of calcium bilirubinate gallstone: role of E coli,
bileduct and bilestones. Z Gastroenterol 1984; 22: 697–700.
beta-glucuronidase and coagulation by inorganic ions,
20 Berkman WA, Bishop AF, Palagallo GL, Cashman MD.
polyelectrolytes and agitation. Ann Surg 1966; 164: 90–100.
Transhepatic balloon dilation of the distal common bile duct and
ampulla of Vater for removal of calculi. Radiology 1988; 167: 26 Goldman LD, Steer ML, Silen W. Recurrent cholangitis after biliary
453–55. surgery. Am J Surg 1983; 145: 450–54.
21 Steidle B, Kurtz B. Transhepatic balloon dilatation of the ductus 27 Bergman JJGHM, Mey S van der, Raues EAJ, et al. Long-term
choledochus and the removal of choledochal calculi. Rofo Fortschr follow-up after endoscopic sphincterotomy for bile duct stones;
Geb Rontgenstr Neuen Bildgeb Verfahr 1991; 155: 128–34. report on 100 patients with a median follow-up of 15 years.
22 Perissat J, Huibregtse K, Keane FBV, Russell RCG, Neoptolemos Gastrointest Endosc 1996; 44: 643–49.
JP. Management of bile duct stones in the era of laparoscopic 28 MacMathuna P, Siegenberg D, Gibbons D, et al. The acute and
cholecystectomy. Br J Surg 1994; 81: 799–810. long-term effect of balloon sphincteroplasty on papillary structure in
23 Carroll BJ, Phillips EH, Chandra M, Fallas M. Laparoscopic pigs. Gastrointest Endosc 1996; 44: 650–55.

Randomised controlled trial of anterior-chamber intraocular


lenses

A Hennig, J R Evans, D Pradhan, G J Johnson, R P Pokhrel, R M C Gregson, R Hayes, R P L Wormald, A Foster

Summary 5·0% of t he A C I OL g roup and 5·4% of c ont rols had


functional vision less than 6/60 (OR 0·93 [0·60–1·43],
Background There are an estimated 16 million people p=0·71) . The c auses of poor vision in t he A CIOL and
blind in both eyes with cataracts. Most live in rural areas control groups were: correctable refractive error (22 and
of developing c ount ries w here surg ic al resourc es are 2 9 ) , u v e i t i s/ se c o n d a r y g l a u c o m a ( 1 3 a n d t w o ) ,
scarce. There is no consensus on the most appropriate endopht hal mi t i s ( four and sev en) , pre- ex i st i ng ey e
type of intraocular lens in situations where high-volume disease ( four and five) , retinal detac hment ( none and
low-cost surgery is required. This study was undertaken four) , cystoid macular oedema ( tw o and none) , corneal
t o evaluat e t he safet y of mult iflex open-loop ant erior- ulcer (one and one), and corneal decompensation (none
chamber lenses (ACIOLs). and one).
Methods 2000 people at t ending Lahan Ey e Hospit al, Interpretation This study provides evidence that, in rural
southern Nepal, with bilateral cataracts reducing vision to areas of developing countries, multiflex open-loop ACIOLs
6/36 or less were randomly allocated to receive standard can be implanted safely by ex perienced ophthalmologists
surgery—intracapsular ex traction ( ICCE) w ith aphakic after routine ICCE, avoiding the disadvantages of aphakic
correction—or ICCE with an ACIOL in their first operated spectacle correction. Further follow-up is planned.
eye. The primary outcome was a visual acuity of less than
6/ 60 in t he operat ed ey e at 1 y ear follow -up. Visual Lancet 1997; 349: 1129–33
acuity was measured for 91% of the cohort at 1 year. The
sample size was estimated to detect a doubling in poor Introduction
v isual out c ome from an est imat ed rat e of 4% in t he There are estimated to be 16 million people bilaterally
standard surgery (control) group. blind with cataracts in the world in 1990, most of whom
Findings The median (range) time taken to do the surgery live in rural areas of developing countries where expert
w as 6·0 ( 3·0–17·2) min for t he A CIOL g roup and 4·1 surgical resources are scarce.1 Cataracts can be taken out
(2·4–10·3) min for the control group. 1 year after surgery, in two ways (see glossary): intracapsular cataract
extraction (ICCE) is simple and quick and involves
removal of the whole lens; extracapsular extraction
Lahan Eye Hospital, Nepal (A Hennig MD, D Pradham MD); (ECCE) removes the lens contents only, leaving the
Department of Opththalmic Epidemiology, Moorfields Eye posterior lens capsule intact. To correct for not having a
Hospital/Institute of Ophthalmology, London EC1V 2PD, UK lens in the eye, (aphakia), either an intraocular lens can
(J R Evans MSc , R P L Wormald FRCOphth); Department of Preventive be implanted during surgery or the patient can use
Ophthalmology, Institute of Ophthalmology, London spectacles or contact lenses after surgery.
(Prof G J Johnson FRCOphth, A Foster FRCOphth);
Nepal Netra Jyoti Singh, Kathmandu, Nepal (R P Pokhrel FRCS); Glossary
Queens Medical Centre, University Hospital, Nottingham ICCE=intracapsular cataract ex traction
(R M C Gregson FRCOphth); and London School of Hygiene and ECCE=ex tracapsular cataract ex traction
Tropical Medicine, London (Prof R Hayes MSc ) PCIOL=posterior chamber intraocular lens
ACIOL=anterior chamber intraocular lens
Correspondence to: Ms J R Evans

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In industrialised countries, the usual surgical Eligible patients (n=2908)


technique is ECCE followed by implantation of a
posterior chamber lens (PCIOL) in the remaining lens Not randomised
capsule. Surgery is done with an operating microscope. Ex cluded (n=379) Refused (n=529)
This technique preserves the structural integrity of the
eye, prevents prolapse of the vitreous body into the
ICCE + ACIOL (n=1002) ICCE + spectacles (n=998)
anterior chamber, and reduces the risk of retinal First operated eye only in trial (standard surgery)
detachment. The disadvantage is that in some patients 98·7% of first eyes operated First operated eye only in trial
blind (visual acuity <3/60) 98·0% of first eyes operated
the posterior capsule will opacify and further Everyone received surgery as blind (visual acuity <3/60)
intervention will be needed. allocated Everyone received surgery as
allocated
Most eye surgeons in rural Africa and Asia have been
trained to do ICCE. In many cases, they do not have
Follow-up at 6 weeks (data not presented)
access to an operating microscope and use a magnifying
loupe to do the operation. Patients receive spectacles Follow-up at 1 year
after the operation. These spectacles are heavy, distort
vision, and are easily broken. Surveys in Africa2 and in
Hospital follow-up 512 (51%) Hospital follow-up 426 (43%)
Asia3 have shown that uncorrected aphakia is one of the Village follow-up 406 (41%) Village follow-up 483 (48%)
most important causes of blindness. Total vision measured 918 (92%) Total vision measured 909 (91%)
Resident not ex amined 51 Resident not ex amined 42
It is accepted that cataract surgeons in developing 45 reported vision OK 36 reported vision OK
countries should use intraocular lenses to overcome the 1 reported vision problems 1 reported vision problems
(but not blind) (but not blind)
difficulties of aphakic spectacles, but there is no Emigrated 3 Emigrated 7
agreement as to whether it is justified to retrain surgeons Died 12 3 reported vision OK
11 reported vision OK Died 27
experienced in ICCE in the ECCE with PCIOL Not traced 18 22 reported vision OK
technique, since this procedure is relatively expensive Total 1002 1 reported vision problems
(but not blind)
and usually requires an operating microscope. Not traced 13
The simplest method of using a lens implant after Total 998
ICCE is to place it in front of the iris in the anterior
chamber of the eye. Older anterior-chamber intraocular Trial profile
lens (ACIOL) implants had a bad reputation because of
faulty design and manufacture.4.5 Studies in
industrialised countries, where ACIOLs are used when cataract extraction was with a cryoextractor. The anterior
chamber was reformed with air. If the pupil was still dilated,
the posterior capsule is ruptured at operation, suggest
acetylcholine was used to constrict it. A drop of
that modern multiflex open-loop ACIOLs are well hydroxypropylmethyl cellulose was put on a standard 19·0 or
tolerated.6–10 There is currently insufficient evidence to 19·5 dioptre single-piece four-point fixation CILCO Kelman
justify their widescale use as a primary procedure in the Multiflex III lens (ALCON, Hemel Hempstead, UK) before
developing world. insertion. Facilities for measuring the power requirement were
After a pilot study,11 we undertook a randomised not available. The corneal section was closed with at least five
controlled trial at Lahan Eye Hospital, southern Nepal, 8/0 virgin silk sutures. In ACIOL operations the air in the
comparing ICCE surgery with a multiflex open loop anterior chamber was replaced by Ringer’s lactate at the end of
ACIOL with ICCE surgery and spectacles. Our the operation. Postoperatively, a sub-conjunctival injection of
hypothesis was that ACIOLs would give better vision gentamycin 20 mg was given in the lower fornix, with
dexamethasone 4 mg in ACIOL operations. Chloramphenicol
after surgery but might be associated with more
or neosporin eye ointment was applied followed by an eye
complications leading to blindness. Lahan is a rural bandage.
eye hospital with three ophthalmologists doing Postoperatively, patients were examined by an
approximately 12 000 eye operations each year. This ophthalmologist daily for 5 days. At discharge on day 6,
paper describes visual outcome 1 year after surgery; patients who had had ICCE only were given +11D spectacles.
analyses of clinical data, quality of life, and cost Follow-up examinations were at 6 weeks and 1 year. Those not
effectiveness will be published elsewehere. returning for follow up were visited by an ophthalmic assistant
who was trained to measure visual acuity and diagnose the
main blinding conditions.
Methods The primary outcome measure was poor vision defined as
Protocol visual acuity less than 6/60 in the operated eye at 1 year follow-
Patients attending Lahan Eye Hospital were eligible if aged up. Visual acuity was measured as the patient presented with or
40–64 years, with bilateral cataract reducing vision to 6/36 or without prescribed spectacles—we measured the functional
less in both eyes, and living within accessible districts. vision the patient was using in everyday life. A modified Snellen
Exclusion criteria were known pre-existing ocular disease, E chart with four optotypes on each line was used. Vision was
hypertension, or diabetes. Patients gave informed consent to taken as the last line on which at least three optotypes were
participate in the trial, which was approved by the Medical read correctly. Best corrected vision after refraction was also
Research Council of Nepal. recorded, with pinhole vision when refraction could not be
ICCE with an ACIOL was compared with ICCE with done on home visits. Early and late surgical complications were
aphakic spectacles. Surgery was done under local anaesthetic by recorded.
two experienced ophthalmologists (AH, DP) with 4·5 loupe A sample size of 2000 was estimated to be capable of
magnification. The horizontal corneal diameter was measured detecting a doubling in poor visual outcome at 1 year in the
and 1 mm added to calculate the diameter of the ACIOL. ACIOL group, at the 5% significance level, with a power of
Three diameters of lens were available: 12 mm, 12·5 mm, and 90%, assuming a 4% prevalence of poor outcome in the control
13·0 mm. A corneoscleral ab-interno incision was made with a group and a follow-up rate of 80%. An interim analysis was
von Graefe knife, with a small conjunctival flap. A peripheral done after 300 patients in each group had been followed up at 6
iridectomy was done at 10 or 2 o’clock positions. Intracapsular weeks and 1 year. The condition for termination was a

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ACIOL Control Causes of poor visual Causes of blindness


outcome (<6/60) (<3/60)
n % n %
ACIOL Control ACIOL Control
Number randomised 1002 100 998 100 n=918 n=909 n=918 n=909
Male 479 47·8 505 50·6 Pre-existing eye disease 4 (0·4%) 5 (0·6%) 3 (0·3%) 2 (0·2%)
Mean (SD) age (yr) 55 (6·6) 55 (6·6) Correctable refractive error 22 (2·4%) 29 (3·2%) 2 (0·2%) 26 (2·9%)
Preoperative visual Complications (sub-total) 20 (2·2%) 15 (1·7%) 12 (1·3%) 14 (1·5%)
acuity in operated eye Endophthalmitis 4 7 4 7
6/60 1 0·1 1 0·1 Corneal decompensation 0 1 0 1
3/60 12 1·2 19 1·9 Corneal ulcer (late) 1 1 1 1
HM/PL 989 98·7 978 98·0 Uveitis/secondary glaucoma 13 2 7 1
HM=hand movements; PL=perception of light. Cystoid macular oedema 2 0 0 0
Retinal detachment 0 4 0 4
Table 1: Study groups
Total 46 (5·0%) 49 (5·4%) 17 (1·9%) 42 (4·6%)
statistically significant increase (1% significance level) in poor Poor functional visual outcome: visual acuity less than 6/60 in operated eye with
visual outcome (best corrected) in the ACIOL group. spectacles if wearing them. Functional blindness: visual acuity less than 3/60 in
operated eye with spectacles if wearing them.
Confidence intervals for odds ratios were calculated by the
Cornfield method.12 Table 3: Causes of poor functional visual outcome and
blindness at 1 year follow up in the operated eye of 1827
patients
Assignment
The unit of randomisation was the patient. The allocation were not in the village when the examiner called. (51
schedule was computer generated in London. Serially ACIOL, 42 control). Visual acuity was measured in 1827
numbered sealed opaque envelopes were prepared and sent to patients (91%) (918 ACIOL, 909 control). Median
Nepal where they were kept locked. Retrieval of the envelopes follow-up time was 60 weeks (range 43–93) for the
required two different keys, one held by the study administrator ACIOL group and 61 weeks (range 43–73) for controls.
and one by one of the surgeons. The first operated eye was For those patients for whom visual acuity was not
entered into the trial. This was agreed by the patient and
measured (82 ACIOL, 91 control), a verbal report on
surgeon and was usually the eye with poorer vision if one eye
was worse. When the patient was on the operating table having
visual status was obtained where possible (57 ACIOL, 63
had local anaesthetic, the envelope assigning the treatment control). For only three people were there reports of
group was opened in view of all the staff present. No-one doing vision problems (one ACIOL, two control).
the study in Nepal was told how the randomisation list was
prepared and no copy of the schedule was kept in Nepal. Analysis
Patients who had an ACIOL and who requested a second eye 1 year after surgery, 5·0% of the ACIOL group and 5·4%
operation were given an ECCE with PCIOL; the second eyes of
of controls had poor visual outcome (OR 0·93
an ICCE-only patients underwent ECCE with spectacles.
[0·60–1·43], 2=0·13, p=0·71) (table 2). Of 46 eyes in
the ACIOL group with poor visual outcome, four had
Masking pre-existing eye disease, 22 had correctable refractive
Because there were obvious differences between the treatment error, and 20 (2·2%) had complications attributable to
groups the trial was not masked.
the surgical procedure. In control eyes with acuity of less
than 6/60, five were due to pre-existing eye disease, 29
Results correctable refractive errors, and 15 (1·7%)
Participants flow and follow up complications attributable to surgery (table 3). There
Figure 1 shows the trial profile. Of 2908 eligible patients were 13 eyes with poor outcome due to uveitis and/or
presenting between February, 1992, and March, 1995, secondary glaucoma in the ACIOL group compared with
379 were excluded for medical reasons and 529 declined: two controls (OR 6·51 [1·47–59·58], 2=8·02, p=0·005),
2000 were randomised—1002 to ICCE and ACIOL and and a further two due to cystoid macular oedema with no
998 to ICCE only (controls), all of whom received the controls so affected. Four control eyes but no ACIOL
assigned procedure. Table 1 shows the age, sex, and eye had retinal detachment. There were ten cases of early
preoperative visual acuity in the two groups. The median endophthalmitis of which six occurred in the control
(range) time taken to do the surgery (mins between group (nine of the ten cases occurred in a 48-h period
placing the superior rectus muscle suture and closing the due to a faulty autoclave). Uncorrected refractive error in
wound) was 6·0 (3·0–17·2) min for the ACIOL group 26 control eyes caused an acuity of less than 3/60
and 4·1 (2·4–10·3) min for the control group. compared with two eyes in the ACIOL group; 4·6% of
At one year, ten patients had emigrated (three ACIOL, control eyes were functionally blind compared with 1·9%
seven control), 39 had died (12 ACIOL, 27 control) and of ACIOL eyes (OR 0·39 [0·21–0·71], 2=11·2,
31 could not be traced (18 ACIOL, 13 control). A p=0·0008).
further 93 were resident but not examined because they Control eyes achieved better visual rehabilitation with

Visual acuity Snellen As functioning at 1 year Best corrected at 1 year


WHO categories acuity
ACIOL Control ACIOL Control
n % n % n % n %
Normal vision 6/6–6/18 416 45·3 540 59·4 824 89·9 847 93·2
Visual impairment 6/24–6/60 456 49·7 320 35·2 69 7·5 42 4·6
Severe visual impairment 5/60–3/60 29 3·2 7 0·8 9 1·0 4 0·4
Blindness 2/60–NPL 17 1·9 42 4·6 15 1·6 16 1·8
Total 918* 100·0 909 100·0 917* 100·0 909 100·0
*One patient did not have best acuity recorded.
Table 2: Visual status at 1 year follow-up in the first operated eye of 1827 patients

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45·3% of ACIOL group achieving an acuity of 6/18 or We anticipated that more people in the ACIOL group
better compared with 59·4% of control eyes (2 36·4, would achieve a functional visual acuity of 6/18 or better
p<0·0001). After correction, 89·9% of ACIOL eyes but the reverse happened. It was observed that people in
compared with 93·2% of control eyes had a vision of the control group improved their visual acuity by tilting
6/18 or better (2 6·48, p=0·01). their head back and looking through the lower portion of
901 (98%) ACIOL eyes and 867 (95%) control eyes their +11·0 spectacles lenses. This induces a prismatic
achieved a better functional visual acuity at 1 year effect and corrects the most common surgically induced
compared with their pre-operative acuity. Four (0·4%) astigmatism (minus cylinder at 90°). The visual results
ACIOL eyes and nine (1%) control eyes had a best for the ACIOL group could be improved if either the
corrected acuity that was worse than their pre-operative required ACIOL power was estimated preoperatively and
acuity. a range of lens power was available for implantation
(which was not the case at Lahan during the study) or
Discussion the residual refractive error in ACIOL eyes was corrected
This study shows that multiflex open-loop ACIOLs can with spectacles after surgery.
be implanted safely by experienced ophthalmologists We cannot explain why more people in the control
after routine ICCE. Approximately 5% of patients had group achieved a very good corrected acuity. A simple
an acuity of less than 6/60 in the trial eye 1 year after explanation is that aphakic spectacles produce image
magnification. Other possibilities include an increased
surgery. In both groups the main cause of poor visual
rate of mild uveitis or mild cystoid macular oedema not
outcome was uncorrected refractive error. In only 2% of
reducing vision to less than 6/60 in the ACIOL group.
people was the reduced vision due to surgical
Immediately after the operation, uveitis was common
complications. By contrast with most surgical trials, this
(99% ACIOL, 89% control) but in most cases was mild
study had a relatively large sample size providing
(a few cells only). However, at 1 year, only eight of 929
reasonably precise estimates of risk of a poor outcome
people followed up at the hospital had mild uveitis which
associated with ACIOL s compared with aphakic
did not reduce vision to less than 6/60 (seven ACIOL,
correction: OR 0·93 (0·6–1·43).
one control). We have no evidence that mild cystoid
We were able to trace 98·5% of the people entering the
macular oedema was more common in the ACIOL
trial, measuring vision on 91% and obtaining verbal
group, although it is possible that we were unable to
reports on vision from a further 6%. An unexpected
detect this with the facilities available.
finding for which we have no explanation was that the
To our knowledge, there are no completed
number of people dying in the ACIOL group was
randomised controlled trials evaluating ACIOLs. The
significantly lower than in the control group (12 vs 27, 2 South Asian Cataract Study Group reported an interim
5·95, p=0·01). Verbal report was available for 11 of the analysis of 6 week follow-up on 343 patients in Nepal;
ACIOL deaths and 23 of the controls indicating no there were more surgical complications overall and more
major problems with vision. This difference in death rate complications at 6 weeks in their ACIOL group than in
is unlikely to bias the study findings. controls.14 Our results correspond well with previous case
As a cause of poor visual outcome in this trial, uveitis series on multiflex open-loop ACIOLs which suggest
and secondary glaucoma occurred more often in the that 70–80% of patients achieve vision of 6/12 or better.
ACIOL group than controls. For those participants who Previous studies have been too small to give good
had received an ACIOL and who wanted surgery on their estimates of the incidence of sight-threatening
other eye, the same surgeons performed ECCE with a complications but do suggest that these occur relatively
PCIOL (437 people). Four eyes receiving a PCIOL had infrequently. Rattigan et al7 did a retrospective analysis
poor visual outcome at 1 year attributable to uveitis or of 50 cases where an ACIOL had been implanted after
secondary glaucoma (0·9%). complications with an ECCE procedure with follow-up
No instance of corneal decompensation resulting from of 3–81 months. There was one case of prolonged uveitis
contact between the ACIOL and the corneal and three cases of cystoid macular oedema, all of whom
endothelium was observed at 1 year. This complication achieved good vision; and two retinal detachments, one
may occur several years after the operation so our follow- of which was due to postoperative trauma. In a
up will continue. There were four cases of retinal prospective study of 90 cases of ACIOL after either
detachment in control eyes but none in the ACIOL ECCE or ICCE, Anmarkrud et al8 found one case of
group. secondary glaucoma, two of corneal oedema, two
People in the ACIOL group had a 60% reduced risk of macular oedema, and one retinal detachment at 1 year.
having a functionally blind eye (visual acuity <3/60) 1 Nikica et al9 found that two of 22 people had cystoid
year after surgery. In the control group there was an macular oedema (detected with fluorescein angiography)
increased risk of functional blindness due to uncorrected 6 months after ICCE with ACIOL. Eriksen and Ring10
refractive error (26 people); 24 (2·4%) of whom were found that two of 60 eyes followed up to 2 years after
people known to be blind because they were not wearing surgery had vision less than 6/12 attributable to the
aphakic spectacles due to loss or breakage and failure to surgery—one case of macular oedema and one retinal
come forward for a replacement pair. Some studies have detachment.
suggested that as many as 46% of patients stop using This study provides evidence that well manufactured
aphakic correction.13 The lower rate observed in our multiflex open loop ACIOLs can be implanted safely by
study probably reflects the relatively short follow-up and experienced ophthalmologists after routine ICCE,
the benefits of participating in a trial. The quality of life avoiding the disadvantages of aphakic spectacle
and cost effectiveness of ACIOLs depend to a large correction. Inserting an ACIOL extended the average
extent on the difficulties of using aphakic spectacles and time of operation by 2 mins. Uveitis and glaucoma as a
their replacement in rural areas of developing countries. cause of visual loss occurred more frequently in the

1132 Vol 349 • April 19, 1997


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ACIOL group. Blindness due to uncorrected refractive 5 Apple DJ, Hansen SO, Richards SC, et al. Anterior chamber lenses.
Part II: a laboratory study. J Cataract Refract Surg 1987; 13: 175–89.
error occurred more commonly in controls. Longer
6 Auffarth GU, Wesendahl TA, Brown SJ, Apple DJ. Are there
follow-up is needed, but the results so far offer hope that acceptable anterior chamber intraocular lenses for clinical use in the
ACIOLs may be a safe alternative to aphakic spectacles 1990s? An analysis of 4104 explanted anterior chamber intraocular
in many parts of the world where there is a need for low- lenses.Ophthalmology 1994; 101: 1913–22.
7 Rattigan SM, Ellerton CR, Chitkara DK, Smerdon DL. Flexible
cost high-volume cataract surgery. open-loop anterior chamber intraocular lens implantation after
We thank patients who took part in the trial and Bindeshwar Mahato posterior capsule complications in extracapsular cataract extraction.
who co-ordinated the study in Lahan; Kedar Timilsina, Janardan J Cataract Refract Surg 1996; 22: 243–46.
Khatiwada, Ganesh Prasad Updahaya, Mahendra Mahato, and 8 Anmarkrud N, Bergaust B, Bulie T, Sand AB. Evaluation of a
Ramchandra Pasman for recruitment of patients, execution of the trial, flexible one-piece open-loop anterior chamber lens “Symflex 350B”
and data collection; and Kristina Hennig for managing data entry and 3–4 years after implantation. Acta Ophthalmol 1993; 71: 796–800.
databases in Kathmandu. At various times over the course of the study, 9 Nikica G, Ljerka HP, Jelena P, Metez-Soldo K, Mladen B. Cystoid
members of the Steering Committee included Noel Rice, Dominic macular edema in anterior chamber lens implantation following
Negrel, Bjorn Thylefors, and Christian Garms. ALCON (UK) donated posterior capsule rupture. Documenta Ophthalmol 1992; 81:
the lenses. The study was funded by Christoffel 309–15.
Blindenmission/Christian Blind Mission International. 10 Eriksen JS, Ring K. Intracapsular cataract extraction with and
without implantation of an anterior chamber lens. A comparative
References study. Acta Ophthalmologica 1985; 63 suppl 173: 74–5.
1 Thylefors B, Negrel D, Pararajasegaram R, Dadzie KY. Global Data 11 Hennig A, Pradhan D, Gregson RMC, Pokhrel RP, Johnson GJ.
on Blindness an Update. World Health Organization. Geneva. Intra-ocular lens implantation during cataract surgery in Nepal
WHO/PBL/94.40. Lancet 1993; 341: 375.
2 Bucher PJM, Ijsselmuiden CB. Prevalence and causes of blindness in 12 Breslow NE, Day NE. Statistical methods in cancer research.
the Northern Transvaal. Br J Ophthalmol 1988; 72: 721–26. Volume 1, page 133. International Agency for Research on Cancer.
3 Directorate General of Health Services (ophthalmology section). IARC Scientific Publications no 32. Lyon. 1980.
Present status of national programme for control of blindness. 1992. 13 Hogeweg M, Sapkota YD, Foster A. Acceptability of aphakic
Government of India. New Delhi-110 011. correction: results from Karnali eye camps in Nepal. Acta Ophthalmol
4 Apple DJ, Brems RN, Park RB, et al. Anterior chamber lenses. 1992; 70: 407–12.
Part I: complications and pathology and a review of designs. 14 South Asian Cataract Management Study Group. The south Asian
J Cataract Refract Surg 1987; 13: 157–74. cataract management study. Br J Ophthalmol 1995; 79: 1029–35.

Effect of renal-artery stenting on progression of renovascular


renal failure

P N Harden, M J MacLeod, R S C Rodger, G M Bax ter, J M C Connell, A F Dominiczak, B J R Junor,


J D Briggs, J G Moss

Summary ang iog raphic rest enosis rat e at 6 mont hs w as 12%


( n=24) . One pat ient died aft er a proc edure-relat ed
Background Placement of renal-artery stents has a high
haemorrhag e. M edian diast olic blood pressure w as
technical success rate in atherosclerotic renovascular
significantly low er after stenting than before ( 95 [ IQR
disease, but little is known about the clinical benefits of
86–103] v s 87 [ 81–90] mm Hg ; p>0·01) but t he
the procedure. We monitored renal function serially before
and after stent insertion in patients w ith renovascular requirement for antihypertensive drugs w as unchanged.
renal failure. Renal function improved or stabilised in 22 (69%) of the
32 patients. Progression of renal failure was significantly
Methods Renal function w as assessed before and after slowed after the procedure; the mean (SE) of the slopes
st ent plac ement by means of serial serum c reat inine of reciprocal serum creatinine values was 4·34 (0·85) L
values in 32 patients w ith atherosclerotic renal-artery mol 1 day 1 before stent placement, and 0·55 (1·0) L
stenosis. The effect on the progression of renal failure mol 1 day 1 after stent placement (p<0·01, two-sample t
w as anal y sed i n 23 pat i ent s by c ompar i son of t he test).
reciprocal slopes of serum creatinine versus time plots
before and after stent placement. Interpretation Renal-stent placement in selected patients
slow s the progression of renovascular renal failure and
Findings 33 t ransluminal st ent s w ere plac ed in 32 may delay the need for renal replacement therapy.
pat ient s w it h at herosc lerot ic renov asc ular disease.
I mmedi at e pat enc y w as ac hi ev ed i n al l c ases; t he Lancet 1997; 349: 1133–36
See Commentary page 1115

Renal Unit and Department of Medicine and Radiology, Introduction


Western Infirmary, Glasgow, UK (P N Harden MRCP ,
M J MacLeod MRCP , R S C Rodger FRCP , G M Baxter FRCR,
Atherosclerotic renal-artery stenosis (ARAS) is an
J M C Connell MD, A F Dominiczak MD, B J R Junor MD, important cause of progressive renal failure, and is
J D Briggs FRCP , J G Moss FRCR) usually associated with widespread atherosclerosis of the
Correspondence to: Dr P N Harden, Department of Nephrology, cerebral, carotid, and peripheral vasculature. 1 The
North Staffordshire Royal Infirmary, Hartshill, Stoke-on-Trent disorder is restricted to the proximal renal artery in many
ST4 7LN, UK cases; aortic atheroma frequently surrounds the ostium

Vol 349 • April 19, 1997 1133

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