Graefe's Archive for Clinical and Experimental Ophthalmology

https://doi.org/10.1007/s00417-019-04336-9

REFRACTIVE SURGERY

Use of low-vault posterior chamber collagen copolymer phakic

intraocular lenses for the correction of myopia: a 3-year follow-up
Khosrow Jadidi 1 & Seyed Aliasghar Mosavi 2 & Farhad Nejat 2 & Neda Mohammadi 3 & Hosein Aghamolaei 4 &
Seyed-Hashem Daryabari 1 & Hamidreza Torabi 1 & Aliagha Alishiri 5

Received: 2 December 2018 / Revised: 16 April 2019 / Accepted: 19 April 2019

# Springer-Verlag GmbH Germany, part of Springer Nature 2019

Abstract
Background Phakic intraocular lens (pIOL) models have indicated an association between cataract formation and inadequate
vaulting. In this study, the efficacy and safety of low-vault posterior chamber pIOLs in the correction of myopia were examined
over 3 years.
Methods From 316 patients undergoing surgery, 14 eyes with a low vault (≤ 150 μm) were examined from 14 patients. After
implanting the Visian Implantable Collamer pIOL for the correction of myopia (moderate and high), the pIOL vault, endothelial
cell loss, uncorrected distance visual acuity (UDVA), corrected DVA (CDVA), and detrimental events were examined over
3 years.
Results Based on the findings, the mean spherical equivalent reduced from − 8.15 ± 3.29 before surgery to − 1.02 ± 0.75 diopters
3 years after the surgery. In terms of visual outcomes, the mean UDVA (Log MAR) significantly increased from 0.95 ± 037 to
0.27 ± 0.28, and the mean CDVA also increased from 0.99 ± 0.11 to 0.06 ± 0.08 (P < 0.05). The mean indices of safety and
efficacy were respectively 1.075 and 0.748. The eyes lost not more than two visual acuity lines. Based on the findings, 82%
achieved 0.80 or better CDVA, while the total endothelial cell loss was 7.96% during 3 years. Overall, vision-threatening
conditions were not reported.
Conclusion The introduced pIOL can be considered a safe and efficient method for myopia at moderate to high levels.

Keywords Phakic intraocular lenses . Vault . Myopia

Introduction
Electronic supplementary material The online version of this article
(https://doi.org/10.1007/s00417-019-04336-9) contains supplementary Phakic intraocular lenses (pIOLs) provide an efficient, pre-
material, which is available to authorized users. dictable, stable, and safe approach for correcting hyperopia
[1, 2], myopia [3, 4], and astigmatism [5, 6]. Nevertheless,
* Seyed Aliasghar Mosavi anterior subcapsular opacities have been reported in several
[email protected] studies [3, 4, 7] with clinically significant cataracts in some
patients. According to the US FDA studies [3, 4], the inci-
1
Health Management Research Center, Baqiyatallah University of dence of anterior subcapsular opacities is estimated at 2.7%
Medical Sciences, Tehran, Iran 3 years following implantation.
2
Vision Health Research Center, Tehran, Iran Peripheral or central crystalline contact with pIOL may
3
Department of Epidemiology and Biostatistics, School of Public lead to the development of an anterior subcapsular cataract.
Health, Tehran University of Medical Sciences, Tehran, Iran Moreover, in older individuals and those with higher my-
4
Applied Biotechnology Research Center, Baqiyatallah University of opia levels, secondary cataract formation affects eyes with
Medical Science, Tehran, Iran insufficient vaulting more significantly [8, 9]. The inci-
5
Department of Ophthalmology, Hormozgan University of Medical dence of cataract development increases as the follow-up
Sciences, Bandar Abbas, Iran progresses [6, 7, 9]. Additionally, localized malnutrition
 Graefes Arch Clin Exp Ophthalmol

secondary to poor aqueous humor circulation seems to be the other hand, up to 1.0 mm was added for eyes with an ACD
another cause of cataract formation [10]. > 3.5 mm. If ACD was < 3.5, the IOL size between the avail-
Design of multiple Implantable Collamer pIOLs has reduced able IOL diameters was rounded down, whereas it was round-
the incidence of cataract formation. Various studies have ed up in case ACD exceeded 3.5 mm. To evaluate the power
assessed the relationship between cataract formation and vault- of pIOL, the pIOL Power Table, as well as a modified vertex
ing [8, 9, 11]. However, there are still controversies. A study by formula, was applied.
Lindland et al. [7] showed no major differences at baseline and Additionally, anterior segment OCT was applied to mea-
accommodation in terms of vault distance. On the contrary, sure vault or central distance of the posterior pIOL surface
studies on the pathophysiology of anterior subcapsular cataracts from the anterior crystalline lens surface at the narrowest
confirm the association between lower vault and cataract devel- site between the surfaces or perpendicular to the crystalline
opment [12, 13]. The present study aimed to examine cataract lens apex. All values were calculated postoperatively dur-
incidence after implanting different Implantable Collamer ing routine examination. Similar lighting conditions and
pIOLs in eyes with poor vault (< 150 μm). necessary measures were considered to prevent the possible
effects of accommodation changes in the anterior surface of
pIOL or crystalline lens, influencing vault measurements.
Methods The literature has suggested the pIOL implantation tech-
nique [7].
This study consisted of patients with pIOL implantation at Cataract was identified clinically after dilatation with myd-
Bina Eye Hospital, Tehran, Iran, from August 2010 to riatic eye drop under slit lamp. If we had any suspicious for
May 2015. Written informed consents were obtained from cataract including the focal dot or stripe anterior opacities or
the participants after the possible risks and details of the the early sign of nuclear changes, we planned using pentacam
surgical procedure were described to them. This study for detecting and grading cataract. Three succeeding measure-
was performed in line with the Declaration of Helsinki, ments are performed in each eye using the 50-scan acquire-
and the review board agreed to its implementation. The ment mode in a dark room. The acquisition with the best
inclusion criteria were as follows: a clear central cornea, centrality of the three are selected and analyzed by the
stable refraction, and corrected distance visual acuity Pentacam Nucleus Staging software to assess lens density.
(CDVA) of 20/50 or higher. The exclusion criteria were The software create a nuclear cataract grade in five stages
as follows: < 18 years of age, anterior chamber depth (Pentacam Nucleus Staging scores) based on the densitometry
(ACD) < 2.8 mm, diagnosis of cataract, endothelial cell values in the three measurements [14].
density (ECD) < 2000 cells/mm2, history of retinal de- Efficacy was defined as the percentage of the eyes achiev-
tachment, ocular inflammation or glaucoma, and diagno- ing a UCVA of 0.50 Log MAR (20/40) or better postopera-
sis of retinopathy and macular degeneration. tively and safety defined as the percentage of the eyes losing
Before implantation of pIOLs, an ophthalmologic exami- more than two lines of BCVA.
nation was performed, including slit lamp evaluation, refrac- Furthermore, uncorrected DVA (UDVA), CDVA, pIOL
tion analysis, Goldmann applanation tonometry, corneal to- vault, loss of endothelial cells, and adverse events were
pography, pachymetry (Orbscan II, Bausch & Lomb), assessed at least 3 years after the implantation of pIOL for
keratometry, ECD analysis, and binocular indirect ophthal- moderate to high myopia.
moscopy. A Visian Implantable Collamer pIOL was applied
in this study. The pIOL models are available in four overall
lengths for myopic, hyperopic, and toric with rectangular, Statistical analysis
7.0 mm width. The most recent pIOL model was implanted
in our study including myopic model (ICMV4), toric model For statistical analysis, SPSS version 24.0 was used. The
(TICMV4), and ICL V4c model, and if possible, emmetropia variations of important factors between before and after
was targeted. Of the total 316 patients that had implantation of intervention were evaluated using paired t test.
pIOL model, 14 cases with low vault of myopic model Descriptive statistics were calculated, and normal distribu-
(ICMV4) were subjected in our study. tion of data was measured by Kolmogorov–Smirnov test.
Using an anterior segment-optical coherence tomography Pearson or Spearman rank correlation tests were per-
(AS-OCT) (Casia SS-100, Tomey Corp, Nagoya, Japan), the formed to determine the correlation between pIOL vault
diameter of pIOL was determined according to ACD, as well and preoperative ACD and WTW diameter and to measure
as horizontal with-to-white (WTW) distance that was sug- differences in pIOL and WTW diameters. Based on the
gested by the manufacturer (nomogram). After the addition result of power analysis, a sample size of 18 achieves
of 0.5 mm to the horizontal WTW calculation, the size of 90% power to detect the difference between them. The
IOL was measured for eyes with an ACD of < 3.5 mm. On level of significance was < 0.05.
Graefes Arch Clin Exp Ophthalmol

Results Table 2 Comparison between preoperative and postoperative visual

outcome

Of 311 patients undergoing surgery, 14 eyes from 14 patients Preoperative 3 years postop P value
(6 women [40%]) with a low vault (≤ 150 μm) were exam-
ined. Tables 1 and 2 present the demographic features, post- UDVA (Log MAR) mean (SD) 0.95 (0.37) 0.27 (0.28) < 0.001
operative visual and refractive data, and pIOL characteristics. CDVA (Log MAR) mean (SD) 0.09 (0.11) 0.06 (0.08) < 0.007
The overall incidence of lens opacities in our study was 1.5% Sphere (D) mean (SD) − 7.46 (3.31) − 0.53 (0.72) < 0.001
(5 of 316) with 6.6 years mean follow-up. However, none of Cylinder (D) mean (SD) − 1.40 (0.66) − 0.99 (0.81) 0.086
low-vault cases had lens opacities. SEQ (D) mean (SD) − 8.15 (3.29) − 1.02 (0.75) < 0.001
The mean spherical equivalent was found to decrease from
Significances are based on paired T test or Wilcoxon signed-rank test
− 8.15 ± 3.29 before the operation to − 1.02 ± 0.75 diopters
UDVA uncorrected distance visual acuity, CDVA corrected distance visual
3 years postoperatively. In terms of visual outcomes, the mean acuity, SEQ spherical equivalent, SD standard deviation, D diopter
UDVA (Log MAR) increased from 0.95 ± 037 to 0.27 ± 0.28, *P < 0.05, **P < 0.01
and the mean value of CDVA also increased from 0.99 ± 0.11
to 0.06 ± 0.08 (P < 0.05). Preoperative ACD (r = − 0.053, P =
0.835), WTW (r = − 0.221, P = 0.379), and age (r = − 0.537, [16, 17]. The present study examined cataract incidence fol-
P = 0.02) had negative relationships with the measured vaults lowing low-vault Implantable Collamer pIOL implantation in
(Fig. 1a–c), while a positive correlation was found with pre- eyes with different refractive errors and ages.
operative spherical equivalent (SEQ) (r = 0.032, P = 0.9) Cataract development and lower vault were not significant-
(Fig. 1d). ly associated in our study, as confirmed in several studies [12,
At the last postoperative visit, 15 eyes (83.3%) had a 13, 18, 19]. In a study by Bleckmann and Keuch [18], five out
UCVA of 20/40 or better). Moreover, ten eyes (55.6%) gained of 127 eyes undergoing surgery developed cataract (vault of
one or more lines of Snellen BCVA and none of the eyes lost 150 μm). Also, a study by Gonvers et al. [15] revealed that
more than two lines of BCVA (see supplemental data).The central vaulting > 90 μm prevents cataract formation in the
mean indices of safety and efficacy were respectively 1.075 crystalline lens due to the inhibition of pIOL contact or prox-
and 0.748. imity to the crystalline capsule. Consequently, it is suggested
Figure 2 presents the course of vault changes following to use greater central vaulting (approximately 150 μm). On
pIOL implantation over the crystalline lens (with and without the other hand, Lindland et al. [7] after evaluating the associ-
a central artificial hole). No significant intergroup differences ation between lens opacity and vaulting did not report any
were found in pIOL vault after surgery; however, the pIOL differences in vault distance during accommodation, as well
vault tended to reduce over time. as the baseline. Although in nine patients, anterior subcapsular
The total endothelial cell loss was estimated at 7.96%, and opacities were developed, pIOL touched the crystalline lens
no vision-threatening complications occurred. only in five eyes.
Previous studies [2, 18] reported an incidence of lens opac-
ities PCPIOL surgery from 1.5 to 25%. Similarly, the overall
incidence of lens opacities in our study was 1.5% (5 of 316)
Discussion with 6.6 years mean follow-up.
Our findings revealed no cataract development and/or
Through trauma or mechanical interaction on the anterior cap- vision-threatening complications after implantation of the
sule, low vault can trigger cataract formation [15]. In other low-vault pIOL. Also, of the total 18 eyes that had implanta-
words, poor vault may interrupt lens nutrition and aqueous tion pIOL, just two cases had implantation with ICL V4c
flow, resulting in metabolic disorders in the crystalline lens model: lens with central artificial hole. Therefore, changes in
design merely aside from vault may not have led to a less rate
Table 1 Characteristics of the participants of cataract induction over time. We assume that other patient-
dependent factors can influence postoperative vault and cata-
Parameter Mean (SD) Mean (range)
ract formation after pIOL implantation.
Age (year) 30.39 (5.4) 18 (23–41) Kamiya et al. [20] found that age and WTW were major
Follow-up (year) 3.40 (1.95) 6.6 (0.4–7) factors influencing vault; in fact, a higher vault was found in
Vault (mm) 0.10 (0.037) 0.11 (0.039–0.15) younger eyes, as well as those with a greater WTW. Likewise,
WTW (mm) 11.53 (0.23) 1.05 (11–12.05)
in the present study, postoperative vault was correlated nega-
ACD (mm) 3.10 (0.19) 0.67 (2.8–3.5)
tively with age (r = − 0.537, P = 0.02). In fact, older patients
had a lower vault, since the anterior chamber reduces due to
WTW white-to-white, ACD anterior chamber depth crystalline lens thickening [21].
 Graefes Arch Clin Exp Ophthalmol

Fig. 1 a–d The correlation between vault and preoperative biometry

Alfonso et al. [9] reported that aside from the older age of of ICL diameter was shown to play a significant role.
eyes which had an anterior subcapsular cataract and tended to Commonly, underestimation is related to poor vault
vault, they also had a smaller pIOL besides a shallower ACD. (250 μm), which is known to increase the risk of cataract.
Despite the similarity of our findings with the literature, low On the other hand, an oversized ICL results in excessive vault
vaulting had no association with cataract formation. Selection (750 μm) and increases the risk of papillary block glaucoma.

Fig. 2 Time of vault changes after PC pIOL implantation with and without a central artificial hole
Graefes Arch Clin Exp Ophthalmol

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