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TAKASHI KOJIMA, SHO YOKOYAMA, MAYUKA ITO, RIE HORAI, SHUYA HARA, TOMOAKI NAKAMURA,
AND KAZUO ICHIKAWA
A
● PURPOSE: To develop and evaluate a new implantable N IMPLANTABLE COLLAMER LENS (ICL; STAAR SUR-
collamer lens (ICL) sizing method that uses high-fre- gical, Monrovia, California, USA) is a posterior
quency ultrasound biomicroscopy (UBM). chamber–type phakic intraocular lens that is de-
● DESIGN: Interventional case series. signed to be implanted in the ciliary sulcus. Determination
● METHODS: ICL were implanted in 47 eyes of 25 of ICL size is crucial in order to achieve a successful result.
patients (8 male, 17 female, mean age 34.7 ⴞ 6.8 years). A too-large ICL will result in shallowness of the anterior
At 3 months after ICL surgery, the vault (distance chamber and an increased risk of angle-closure or pupillary
between ICL and crystalline lens) was measured using block glaucoma.1,2 On the other hand, a too-small ICL will
anterior optical coherence tomography (OCT). Stepwise result in a decreased distance between the ICL and
multiple regression analysis was performed in order to crystalline lens and in an increasing risk of cataract
determine the optimal ICL size that will be expected to formation.3–5 Conventionally, ICL size has been deter-
achieve a 0.5-mm vault, and the regression equation was mined based on the horizontal corneal diameter (white-
calculated. Mean keratometric power, axial length, anterior to-white, WTW) and anterior chamber depth (ACD).
chamber depth, sulcus-to-sulcus (STS) diameter, and dis- However, accumulated reports have revealed that there is
tance between STS plane and crystalline lens were applied a poor correlation between ciliary sulcus-to-sulcus (STS)
as candidates for explanatory variables. Subsequently, the diameter and WTW measurement.6 –10 Choi and associ-
equation was applied to a new group of patients (81 eyes of
ates determined ICL size using conventional 50-MHz
43 patients, 20 male and 23 female, mean age 35.6 ⴞ 7.2
ultrasound biomicroscopy (UBM).11 Even though only a
years) in order to decide the ICL size. Postoperative vault
small number of cases were evaluated, the UBM method
was evaluated at 3 months after surgery. Main outcome
was superior to conventional methods for achieving a
measures were mean postoperative vault and percentages of
moderate vault. The emergence of high-frequency UBM
eyes that achieved moderate vault.
● RESULTS: The regression equation was determined
with a wide scanning field has enabled direct measurement
using 3 explanatory variables: anterior chamber depth of STS diameter.
(ACD), STS diameter, and distance between STS plane Vault changes according to the difference between ICL
and anterior crystalline lens surface (STSL). The mean size and STS diameter. Gonvers and associates reported
vault error (postoperative vault – predicted vault) was that there was no contact between the ICL and crystalline
ⴚ0.06 ⴞ 0.29 mm. Of the total number of eyes, 88.9% lens in cases with the central vaulting equal to or greater
had a vault between 0.15 and 1.0 mm. None of the eyes had than 0.15 mm.3 They concluded that 0.15 mm of central
a low vault (<0.15 mm). Nine eyes (11.1%) had a high vaulting should be the minimum target for ICL implanta-
vault (>1.0 mm). tion. Therefore, in the present report, the lower limit of
● CONCLUSION: A novel ICL sizing equation was devel- vaulting was set at 0.15 mm.
oped and shown to be an effective method for calculation Recently, Dougherty and associates conducted a multi-
of the optimal ICL size in order to achieve an appropriate center study that reported a regression equation to calcu-
vault. (Am J Ophthalmol 2012;153:632– 637. late optimal ICL size.12 They used STS and ICL power as
© 2012 by Elsevier Inc. All rights reserved.) explanatory variables. Since the distance between the
fixed position of the ICL and crystalline lenses can affect
ICL vault, a new parameter was created in the present
Accepted for publication Jun 24, 2011. study: the distance between STS plane and anterior
From Nagoya Eye Clinic, Nagoya, Japan (T.K., M.I., R.H., S.H., T.N.);
Department of Ophthalmology, Keio University School of Medicine,
crystalline lens surface (STSL).
Tokyo, Japan (T.K.); and Department of Ophthalmology, Social Insur- The purpose of this study was to develop an equation using
ance Chukyo Hospital, Aichi, Japan (S.Y., S.H., K.I.). stepwise multiple regression analysis for determination of
Inquiries to Takashi Kojima, Department of Ophthalmology, Keio
University School of Medicine, Shinanomachi 35, Shinjuku-ku, Tokyo appropriate ICL size, and then to validate the efficacy of the
160-8582, Japan; e-mail: tkojkoj@mac.com equation by investigating postoperative vault.
METHODS Carl Zeiss Meditec). From the observation that ICL vault
increases 1.1 times higher along the compression length in
● SUBJECTS IN THE IMPLANTABLE COLLAMER LENS SIZ- a balanced salt solution (BSS) (STAAR proprietary data),
ING EQUATION STUDY: A total of 45 eyes of 24 con- optimal ICL size to achieve 0.5-mm vault was estimated
secutive patients (12 male, 12 female, mean age 34.3 ⫾ with the following equation:
6.6 years) who underwent ICL surgery at Nagoya Eye
Clinic were enrolled in the study. Patient demographics Optimal ICL size ⫽ Implanted ICL size ⫹ (0.5
are shown in Table 1. Patients were excluded if they had
other ocular diseases except for refractive error. The ⫺ Postoperative vault) ⁄ 1.1.
mean manifest refractive sphere and cylinder of these Then, stepwise multiple regression analysis was per-
subjects were ⫺9.22 ⫾ 3.08 diopters (D; range ⫺3.75 to formed in order to evaluate the correlation between
⫺24.0 D) and ⫺0.95 ⫾ 0.78 D (range 0 to ⫺2.75 D), optimal ICL size and other ocular parameters. The
respectively. The ICL size was determined with a dependent variable was optimal ICL size. The candi-
conventional STAAR sizing nomogram that calculated dates of an explanatory variable included mean kerato-
the size from the 2 parameters of WTW and anterior metric value, axial length, STS, STSL, and ICL
chamber depth.13 spherical power. In the regression analysis, a variance
inflation factor was calculated and the amount of
● REGRESSION EQUATION VALIDATION STUDY SUB-
multicollinearity was assessed.
JECTS: A total of 81 eyes of 43 patients (21 male, 22
female, mean age 35.6 ⫾ 7.2 years) who underwent ICL
● ULTRASOUND BIOMICROSCOPY SCANNING SYSTEM: A
implantation surgery were enrolled in the study. Patient
high-frequency B-scan diagnostic ultrasound biomicros-
demographics are shown in Table 2. The mean manifest
refractive sphere and cylinder of these subjects were copy imaging system (VumaxII) was employed in the
⫺9.21 ⫾ 3.34 D (range ⫺3.25 to ⫺24.0 D) and ⫺1.12 ⫾ present study. The system has a scanning field depth of
0.95 D (range 0 to ⫺3.75 D), respectively. 18.5 ⫻ 14 mm, and can capture the entire anterior
segment in a single scan. The sampling rate was 22
● MULTIPLE REGRESSION ANALYSIS: Before ICL im- frames/s. A headpiece with a 35-MHz transducer was
plantation surgery, mean keratometric value (ARK-530A; used for STS and STSL measurement. The axial and
Nidek, Gamagori, Japan), axial length (IOL Master; Carl lateral resolution in the anterior segment with a 12-mm
Zeiss Meditec, Jena, Germany), anterior chamber depth height were 0.022 mm and 0.38 mm, respectively. The
(IOL Master; Carl Zeiss Meditec), and STS (VumaxII; repeatability of STS measurements has been previously
SONOMED Inc, Lake Success, New York, USA) and evaluated, and the coefficient of variation was 0.62%.14
STSL (VumaxII) were measured. At 3 months after A single, experienced examiner carried out all UBM
surgery, vault was measured using anterior OCT (Visante; measurements.
ACD ⫽ anterior chamber depth; STS ⫽ sulcus-to-sulcus diameter; STSL ⫽ STS to anterior lens
surface distance; VIF ⫽ variance inflation factor.
TABLE 4. Comparison of Postoperative Vault in the Current Study With Predicted Vault if STAAR Sizing Nomogram or
Dougherty’s Nomogram Is Applied to Determine Implantable Collamer Lens Size
Distribution of 3-month postoperative vault in the current 0 (0%) 72 (88.9%) 9 (11.1%) Current equation vs STAAR
study, number of eyes (percentage) nomogram: P ⬍ .001
Distribution of predicted vault when ICL size was 13 (16.0%) 54 (66.7%) 14 (17.3%) Current equation vs
calculated by STAAR nomogram, number of eyes Dougherty’s nomogram:
(percentage) P ⫽ .036 STAAR
Distribution of predicted vault when ICL size was 6 (7.4%) 69 (85.2%) 6 (7.4%) nomogram vs
calculated by Dougherty’s nomogram, number of eyes Dougherty’s nomogram:
(percentage) P ⫽ .022
value, axial length, STS, STSL, and ICL spherical power Moreover, all of the patients in the present study were
were considered explanatory variable candidates for predic- Japanese. It is possible that there is variation in terms of
tion of optimal ICL size. There are other possible explanatory anatomic features of the ciliary sulcus between ethnic
variable candidates, such as iridocorneal angle, crystalline groups, and the present regression equation should be
lens thickness, crystalline lens radius, and detailed design of carefully applied with this in mind in different patient
ICL. Further validation of the equation is needed with populations. Previous studies also have shown that inter-
inclusion of other ocular and ICL parameters in the future. examiner variation of STS measurements by UBM was
In the present study, it was assumed that ICL was fixed in relatively high while intra-examiner variation was low.14 If
the ciliary sulcus. A previous study by García-Feijoó and STS measurements are carried out by several examiners,
associates, using UBM, showed that haptics were folded and inter-examiner variation should be validated before mea-
impacted in the ciliary body in some cases.17 If ICL was not surement values are applied to select ICL size.
fixed in the sulcus, the present equation could not achieve an Although the lower limit of vault was reported by
optimal ICL vault. Future investigations to improve the Gonvers3 to be 0.15 mm, there is no evidence on how high
fixation method of ICL should be performed. a vault is acceptable. Since a high vault can cause angle
There are limitations to the present study. The regres- closure, the association between ICL vault and iridocor-
sion equation was developed from a relatively small num- neal angle also should be evaluated in future studies.
ber of cases. Even if the R2 of the regression was high, a The ICL is manufactured with 0.5-mm increments in
larger number of cases is needed to optimize the equation. length. This means, then, that if an ICL with 0.5 mm
THE AUTHORS INDICATE NO FUNDING SUPPORT OR FINANCIAL CONFLICTS OF INTEREST. INVOLVED IN DESIGN AND
conduct of the study (T.K., T.N., K.I.); collection, management, analysis, and interpretation of the data (T.K., S.Y., M.I., R.H., S.H.); and preparation,
review, or approval of manuscript (T.K., S.Y., M.I., R.H., S.H., T.N., K.I.). The protocol of this study was approved by the Institutional Review Board
of the Nagoya Eye Clinic and the study procedures conformed to the ethical principles for research involving human subjects as outlined in the
Declaration of Helsinki. Informed consent was obtained from all subjects after receiving an explanation of the nature and possible consequences of taking
part in the study.