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Hennig 1997
Hennig 1997
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,
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beta-glucuronidase and coagulation by inorganic ions,
20 Berkman WA, Bishop AF, Palagallo GL, Cashman MD.
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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.
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
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
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