Abstract
Purpose
To determine the risk factors and incidence of cataract formation over a long-term mean follow-up of 7.5 years after type V4 implantable collamer lens (ICL) implantation.
Methods
We analyzed the preoperative, 3-month postoperative, 3-year postoperative, and last follow-up data of 228 eyes (118 patients) with mean preoperative spherical equivalent of -12.7 D and minimum postoperative follow-up of 3 years. Additionally, we determined the risk factors for cataract formation and calculated the 10.3 year cumulative cataract formation rate and 10.3 year cumulative cataract surgery rate using a survival curve.
Results
After type V4 ICL implantation with minimum follow-up of 3 years, the calculated 10.3 year cumulative cataract formation rate was 20% and actual cataracts developed in 34 eyes (14.9%). The 10.3 year cumulative cataract surgery rate was 12% based on a survival curve and actual cataract surgery was performed in 12 eyes (5.3%). The risk factors for cataract formation were age (odds ratio [OR] = 1.10, p = 0.00), preoperative spherical equivalent (OR = 0.90, p = 0.00), crystalline lens thickness (OR = 9.54, p = 0.00), axial length (OR = 1.33, p = 0.00), 3 months postoperative vault (OR = 0.50, p = 0.03), and existence of peripheral touch between ICL optic margin and crystalline lens at last follow-up (OR = 7.84, p = 0.00).
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![]() | Figure 1.Superior or inferior peripheral crystalline lenticular touch by superior or inferior periphery of implantable collamer lens (ICL). (A) The arrows indicate the superior or inferior periphery of ICL is not touching the crystalline lens and there is no cataract formation. (B) It shows visually significant anterior subcapsular opacity. (C) The same eye with (B) shows the superior periphery of ICL is touching the crystalline lens (arrow). |
![]() | Figure 2.Life table for cataract formation after implantable collamer lens (ICL) implantation. The moments when the initial cataract developed in group A or B patients after ICL implantation were regarded as “censored” in this survival curve. |
![]() | Figure 3.Life table for cataract surgery after implantable collamer lens (ICL) implantation. The moments when the patients in group A underwent cataract surgery were regarded as “censored” in this survival curve. |
Table 1.
Preoperative patient demographics
Values are presented as mean ± SD unless otherwise indicated. Age = age at implantable collamer lens implantation; SE = spherical equivalent; IOP = intraocular pressure; LT = crystalline lens thickness; ACD = anterior chamber depth; AXL = axial length; WWD = white to white diameter measured with caliper; CCT = central corneal thickness; BCVA = best corrected visual acuity; UCVA = uncorrected visual acuity.
Table 2.
Time to develop initial late onset cataract*
Time to initial cataract (years) | Range (years) | |
---|---|---|
Group A (n = 13) | 2.6 ± 2.0 | 0.3-4.5 |
Group B (n = 21) | 4.7 ± 1.3 | 0.9-9.1 |
Table 3.
Patterns of cataract after ICL implantation (number of eyes)
ASCO only | PSCO only | NS only | ASCO + PSCO | ASCO + NS | ASCO +NS + PSCO | NS + PSCO | Total | |
---|---|---|---|---|---|---|---|---|
Group A | 4 | 0 | 1 | 6 | 1 | 1 | 0 | 13 |
Group B | 10 | 4 | 0 | 6 | 0 | 0 | 1 | 21 |
Table 4.
Touch between ICL optic periphery and crystalline lens at last follow up*
Group A (n = 13) | Group B (n = 21) | Group C (n = 194) | |
---|---|---|---|
No. of eyes (%) | 6 (46) | 2 (10) | 4 (2) |
Table 5.
Risk factors for cataract formation after ICL implantation by univariate Cox’s propotional hazards
Parameter | Group A + B (34 eyes)(Cataract group) | Group C (194 eyes)(No cataract group) | OR (95% CI) | p-value |
---|---|---|---|---|
Age (years) | 38.0 ± 8.3 | 29.8 ± 7.6 | 1.10 (1.06-1.14) | 0.00 |
Preoperative SE (diopters) | -15.2 ± 4.6 | -12.2 ± 4.2 | 0.90 (0.84-0.96) | 0.00 |
Preoperative LT (mm) | 3.92 ± 0.36 | 3.71 ± 0.26 | 9.54 (3.19-28.51) | 0.00 |
Preoperative AXL (mm) | 29.2 ± 1.70 | 27.9 ± 1.84 | 1.33 (1.13-1.57) | 0.00 |
Vault 3m (CCT) | 1.3 ± 0.6 | 1.5 ± 0.7 | 0.50 (0.27-0.94) | 0.03 |
(range 0-3.0) | (range 0.3-4.0) | |||
Last peripheral touch* (eyes) | 8/34 (24%) | 4/194 (2%) | 7.84 (3.53-17.39) | 0.00 |
Table 6.
Comparison of crystalline lens thickness between cataract group and no cataract group*
Group A + B (Cataract group) | Group C (No cataract group) | |
---|---|---|
Preoperative LT >4 mm (eyes) | 13 (38) | 23 (12) |
Preoperative LT ≤4 mm (eyes) |
21 (62) |
171 (88) |
Total | 34 (100) | 194 (100) |
Table 7.
Comparison of age between cataract group and no cataract group in eyes with thick crystalline lens*
Group A + B (Cataract group) | Group C (No cataract group) | |
---|---|---|
Preoperative LT >4 mm, Age ≤35 (eyes) | 2 (15) | 11 (48) |
Preoperative LT >4 mm, Age >35 (eyes) |
11 (85) |
12 (52) |
Total | 13 (100) | 23 (100) |
Table 8.
Risk factors for clinically significant cataract formation by univariate Cox’s propotional hazards
Parameter | Group A (13 eyes) | Group B (21 eyes) | OR (95% CI) | p-value |
---|---|---|---|---|
Vault 3mo (CCT) | 0.9 ± 0.3 (range 0.4-1.3) | 1.5 ± 0.7 (range 0-3.0) | 0.29 (0.11-0.75) | 0.01 |
Last peripheral touch* (eyes) | 6/13 (46%) | 2/21 (10%) | 4.19 (1.27-13.79) | 0.02 |
Table 9.
Changes of postoperative values over time after ICL implantation
Table 10.
Adverse events after ICL implantation
Adverse event | No. of eyes |
---|---|
Retinal detachment | 2 (0.9) |
Myopic CNV | 3 (1.3) |
Pigment dispersion glaucoma | 2 (0.9) |
Turbid ICL | 2 (0.9) |
Immediate postoperative sterile hypopyon |
2 (0.9) |
Total | 11 (4.8) |