Abstract
Purpose:
To report 5-year outcomes following surgery for cataract associated with persistent fetal vasculature (PFV).
Design:
Clinical cohort study using pediatric cataract registry data collected annually from medical records.
Methods:
64 children <13 years of age, undergoing surgery for unilateral, non-traumatic cataract associated with PFV were included. Proportions with age-normal visual acuity (VA) and VA better than 20/200 at 5 years follow-up were estimated. Cumulative incidences of complications and additional surgeries by 5 years were calculated. Outcomes were compared between unilateral PFV eyes and eyes with unilateral non-PFV cataract from our registry.
Results:
48 of 64 eyes were aphakic postoperatively (median age at surgery 2 months, range 1–13) and 16 were pseudophakic (29 months, range 2 to 92). Overall, 4 of 42 eyes (10%, 95% CI: 3%−23%) achieved age-normal visual acuity. VA better than 20/200 was achieved in 17 (59%, 95% CI 39%−76%) unilateral aphakic PFV eyes and 44 (43%, 95% CI 32%−54%) unilateral non-PFV aphakic eyes (age-adjusted OR=1.90; 95% CI: 0.81–4.50; P=0.14). The most common complication in aphakic PFV eyes was glaucoma-related adverse events (GRAE) (cumulative incidence 24%, 95% CI: 9%−37%). There was no significant difference in GRAE between PFV and non-PFV eyes in aphakic participants ≤1 year of age at lensectomy (age-adjusted HR=1.20, 95% CI: 0.54–2.64, P=.66).
Conclusions:
A wide range of visual outcomes for PFV cataract were observed with a 10% probability of achieving age-normal VA. There was an ongoing risk for the development of glaucoma-related adverse events in PFV eyes.
Table of Contents Statement:
We studied the outcomes of 64 children undergoing surgery for unilateral, non-traumatic cataract associated with persistent fetal vasculature; 48 were left aphakic and 16 pseudophakic. A range of visual outcomes for persistent fetal vasculature cataract were observed with a 10% probability of achieving age-normal VA. There was a 24% cumulative incidence of glaucoma-related adverse events in aphakic eyes, which was similar to that for a comparison group of eyes without persistent fetal vasculature.
Introduction
Evidence of persistent fetal vasculature (PFV) is seen in approximately 20% of infantile and childhood cataracts.1,2 Anatomic abnormalities can be found in the anterior segment alone, or in both anterior and posterior segments, resulting in highly variable presentations. Severe cases can present with cataract, retinal detachment, optic nerve abnormality, and macular hypoplasia/dystopia and have poor visual potential.
We describe visual acuity (VA) outcomes and complications associated with PFV cataract 5 years following lensectomy in a large cohort of children enrolled in the Pediatric Eye Disease Investigator Group (PEDIG) cataract registry.3 These findings are compared with a similarly aged group of eyes without PFV in the cataract registry.
Methods
The study was supported through a cooperative agreement with the National Eye Institute of the National Institutes of Health. An Investigational Device Exemption (#G110149) was obtained from the United States Food and Drug Administration for use of an intraocular lens in children. The protocol and Health Insurance Portability and Accountability Act-compliant informed consent forms were approved by each site’s institutional review board. The parent or guardian of each child provided written informed consent; assent was obtained from children 7 years of age or older.
Participants
Of 994 children (<13 years of age) enrolled in the prospective PEDIG cataract registry,3 64 underwent lensectomy for unilateral cataract associated with PFV. Outcomes from 3 participants with bilateral PFV cataracts were excluded (insufficient number for separate analyses). A minimum of 160 days follow-up was required.
Data Collection
Cataract surgery was performed prior to consent and enrollment. Data were collected annually from medical record review, including complications and additional diagnoses or surgeries that occurred within 5 years after lensectomy.
Study-specific Definitions
PFV cataract was identified by investigators based on clinical features. Eyes were classified as having posterior segment involvement if abnormalities consistent with PFV were noted in the vitreous, retina, or optic nerve. Otherwise, eyes were classified as anterior PFV. Study definitions were provided for the diagnosis of glaucoma and glaucoma suspect.4 The term glaucoma-related adverse event includes both glaucoma and glaucoma suspect. Unilateral cataract was defined as only one eye having lensectomy during the study period. The categorization of aphakia or pseudophakia is in reference to IOL implantation at the time of lensectomy, irrespective of whether secondary IOL surgery was performed at a subsequent date.
Statistical Methods
For analysis of visual acuity (VA), data were included if collected between 4 years (≥1461 days) and 6 years (≤2191 days) after lensectomy. Monocular optotype VA was converted to logMAR values of 0.0 to 1.6 by 0.1 logMAR increments (approximate Snellen VA 20/20 to 20/800). VA worse than the range of the VA testing method was assigned a value of 1.7 for <20/800, 1.8 logMAR for counting fingers, or 1.9 logMAR for hand motion, light perception, or no light perception. Median (interquartile range [IQR]) VA is provided for the 5-year outcome, and distributions were compared between eyes with anterior vs. posterior segment PFV using a Wilcoxon Rank Sum Test with HodgesLehmann estimator. Due to the small number of PFV eyes, the proportions of eyes with age-normal VA5,6 and with better than 20/200 (1.0 logMAR) are reported using the Clopper-Pearson exact 95% confidence interval (CI). The proportion of eyes with posterior segment PFV was compared between those with aphakia vs. pseudophakia using logistic regression and the odds ratio, adjusting for age (continuous) at lensectomy.
We compared VA outcomes between PFV eyes and eyes with unilateral, non-traumatic, non-PFV cataract from our registry using logistic regression and the odds ratio. These models also were used to estimate proportions and Wald 95% CIs of PFV and non-PFV eyes with age-normal VA and better than 20/200 VA. Due to a dissimilar age distribution between PFV and non-PFV eyes, the model for VA better than 20/200 was adjusted for age (continuous), with the difference in proportions between the PFV and non-PFV eyes estimated at the mean age of PFV eyes (2.4 months for aphakic cases, and 2.7 years for pseudophakic cases). Adjustment for age in the age-normal VA comparison was not performed, as that outcome already accounts for expected differences in VA according to age.
A Cox proportional-hazards (Cox PH) model was used to estimate the 5-year cumulative incidence and corresponding 95% CI for specified complications and additional surgeries according to primary IOL implantation (aphakic or pseudophakic). Eyes with glaucoma at enrollment were excluded from the cumulative incidence calculations for all glaucoma-related outcomes. We also compared hazards of glaucoma-related adverse events in PFV and non-PFV (unilateral, non-traumatic cataract) using Cox PH, adjusting for age at lensectomy (0 to <4 months, 4 to <8 months, 8 to <12 months). The model was limited to aphakic participants 1 year of age or younger (75th percentile of age at lensectomy for PFV eyes) due to a small number of pseudophakic PFV eyes.
Unless indicated as overall estimates, all analyses were stratified by aphakia vs. pseudophakia, or by anterior vs. posterior segment PFV; sample size did not permit subdivision by these criteria simultaneously.
Analyses were performed using SAS version 9.4 (SAS Institute Inc., Cary, NC).
Results
Of 64 eyes with PFV, 48 (75%) eyes were aphakic and 16 (25%) pseudophakic after lensectomy. Overall, 18 (28%) PFV eyes had posterior segment abnormalities (11 aphakic and 7 pseudophakic). The mean (SD) follow-up for all children was 50 months (±19 months) and median was 58 months (range 5 to 77). Median follow-up was 58 months (range 5 to 77) for aphakic and 58 months (range 6 to 65) for pseudophakic eyes. Median age at lensectomy was 2 months (range 1 to 13) for aphakic and 29 months (range 2 to 92) for pseudophakic eyes. Anterior vitrectomy at the time of cataract surgery was performed in 46 of 48 (96%) eyes left aphakic and 12 of 16 (75%) eyes left pseudophakic. Demographic and clinical characteristics are in Table 1 and eTable 1 for participants with PFV cataract (n=64), as well as non-PFV unilateral cataract surgery (n=405) for reference.
Table 1.
Baseline Clinical Characteristics of Participants with Unilateral Persistent Fetal Vasculature (PFV) Cataract and Comparison Groups without PFV Cataract
| PFV Cataract |
Non-PFV Cataract |
|||||||
|---|---|---|---|---|---|---|---|---|
| Aphakia | Pseudophakia | Aphakia | Pseudophakia | |||||
| N | % | N | % | N | % | N | % | |
|
|
|
|||||||
| Total participants | 48 | 100% | 16 | 100% | 136 | 100% | 269 | 100% |
| Sex | ||||||||
| F | 24 | 50% | 7 | 44% | 84 | 62% | 127 | 47% |
| M | 24 | 50% | 9 | 56% | 52 | 38% | 142 | 53% |
| Race | ||||||||
| Black/African American | 5 | 10% | 0 | 0 | 12 | 9% | 39 | 14% |
| Non-white Hispanic | 2 | 4% | 0 | 0 | 5 | 4% | 18 | 7% |
| White | 36 | 75% | 14 | 88% | 105 | 77% | 186 | 69% |
| Other | 4 | 8% | 2 | 13% | 11 | 8% | 19 | 7% |
| Unknown/not reported | 1 | 2% | 0 | 0 | 3 | 2% | 7 | 3% |
| Age at lensectomy | ||||||||
| 0 to <3 months | 36 | 75% | 1 | 6% | 63 | 46% | 0 | 0 |
| 3 to <6 months | 6 | 13% | 0 | 0 | 25 | 18% | 1 | 0% |
| 6 to <9 months | 2 | 4% | 1 | 6% | 10 | 7% | 3 | 1% |
| 9 to <12 months | 2 | 4% | 2 | 13% | 16 | 12% | 9 | 3% |
| 1 to <3 years | 2 | 4% | 6 | 38% | 8 | 6% | 47 | 17% |
| 3 to <8 years | 0 | 0 | 6 | 38% | 8 | 6% | 134 | 50% |
| 8 to <13 years | 0 | 0 | 0 | 0 | 6 | 4% | 75 | 28% |
| Mean (SD) age | 3 months (3) | 3.0 years (2.4) | 13 months (27) | 6.0 years (3.3) | ||||
| Median (range) age | 2 months (1 to 13) | 2.4 years (0.1 to 7.6) | 4 months (<1 to 155) | 5.7 years (0.4 to <13) | ||||
| Birth weight | ||||||||
| <=1500 grams | 0 | 0 | 1 | 6% | 5 | 4% | 12 | 4% |
| >1500 to 2000 grams | 0 | 0 | 1 | 6% | 2 | 1% | 4 | 1% |
| >2000 to 2500 grams | 4 | 8% | 0 | 0 | 9 | 7% | 17 | 6% |
| >2500 to 4000 grams | 34 | 71% | 10 | 63% | 102 | 75% | 166 | 62% |
| >4000 grams | 6 | 13% | 2 | 13% | 10 | 7% | 29 | 11% |
| Unknown | 4 | 8% | 2 | 13% | 8 | 6% | 41 | 15% |
| Family history of infantile or juvenile cataract | ||||||||
| Yes | 2 | 4% | 1 | 6% | 7 | 5% | 24 | 9% |
| No | 46 | 96% | 14 | 88% | 125 | 92% | 232 | 86% |
| Unknown | 0 | 0 | 1 | 6% | 4 | 3% | 13 | 5% |
| Postmenstrual birth age | ||||||||
| <32 weeks | 0 | 0 | 1 | 6% | 5 | 4% | 12 | 4% |
| 32 to <37 weeks | 2 | 4% | 0 | 0 | 6 | 4% | 23 | 9% |
| 37 to <42 weeks | 45 | 94% | 15 | 94% | 118 | 87% | 208 | 77% |
| >=42 weeks | 0 | 0 | 0 | 0 | 2 | 1% | 6 | 2% |
| Unknown | 1 | 2% | 0 | 0 | 5 | 4% | 20 | 7% |
| Current medical condition | ||||||||
| Yes | 5 | 10% | 1 | 6% | 35 | 26% | 78 | 29% |
| No | 43 | 90% | 15 | 94% | 100 | 74% | 191 | 71% |
| Unknown | 0 | 0 | 0 | 0 | 1 | 1% | 0 | 0 |
Note. Current medical conditions in PFV eyes which were documented at the time of registry enrollment included glaucoma, albinism, gastroesophageal reflux (GERD), epispadias, and a patent ductus arteriosus requiring ligation.
Visual Acuity
Five-year VA scores were available for 42 of 64 eyes (66%), with a similar age distribution between those with and without VA reported at outcome (eTable 2). Overall, only 4 of 42 eyes (10%, 95% CI: 3% to 23%) achieved age-normal VA, while 20 (48%, 95% CI: 32%−64%) achieved better than 20/200.
For aphakic eyes, median VA was 20/100 (IQR 20/50–20/320) for PFV eyes and 20/200 (IQR 20/63–20/640) for non-PFV eyes. Mean age at lensectomy for aphakic eyes with available VA scores was 2.4 months for PFV eyes (n=29) and 11.6 months for non-PFV eyes (n=95). VA better than 20/200 was achieved by 17 (59%, 95% CI 39%−76%) unilateral aphakic PFV eyes and 44 (43%, 95% CI 32%−54%) unilateral aphakic eyes with non-PFV cataract in our registry (age-adjusted OR=1.90; 95% CI: 0.81–4.50; P=0.14). Age-normal VA was achieved in 3 of 29 (10%, 95% CI 2%−27%) aphakic PFV eyes and in 12 of 95 (13%, 95% CI 7%−21%) aphakic non-PFV eyes (OR=.80, 95% CI: .21 to 3.05; P =.74).
For pseudophakic eyes, median VA was 20/400 (IQR 20/200 to <20/800) for PFV eyes (eFigure 1) and 20/63 (IQR 20/32–20/200) for non-PFV eyes. Mean age at lensectomy for pseudophakic cases with available VA scores was 2.7 years for PFV eyes (n=13) and 5.9 years for non-PFV eyes (n=172). VA better than 20/200 was achieved by 3 (23%, 95% CI: 5%−54%) pseudophakic PFV eyes and 129 (68%, 95% CI: 58%−77%) pseudophakic non-PFV eyes (age-adjusted OR=0.14; 95% CI: 0.04–0.54; P=.005). Age-normal VA was achieved in 1 of 13 (8%, 95% CI 0%−36%) pseudophakic PFV eyes and in 33 of 172 (19%, 95% CI 14%−26%) pseudophakic non-PFV eyes (OR=.35, 95% CI: .04 to 2.80; P=.32).
Comparing the distribution of VA at 5 years in eyes with posterior PFV to eyes with only anterior PFV, we found 20/800 (IQR: 20/80 to <20/800) and 20/100 (IQR: 20/50 to 20/320), respectively (difference=4 logMAR lines, 95% CI: 0 to 7, P=.09; eFigure 1). Fifteen of 28 (54%, 95% CI: 34%−72%) with anterior and 5 of 14 (36%, 95% CI: 13%−65%) eyes with posterior PFV had VA better than 20/200 (OR=2.08, 95% CI: 0.55 to 7.79, P=.28). Age-normal VA at the 5-year outcome was achieved in 11% (95% CI: 2%−28%) of eyes with anterior PFV and in 7% (95% CI: 0%−34%) with posterior PFV (OR=1.56, 95% CI: .15 to 16.53; P=.71). A greater proportion of pseudophakic eyes had posterior segment disease (6 of 13, 46%) compared with aphakic eyes (8 of 29, 28%); however, the age-adjusted odds ratio was not statistically significant (OR=4.47, 95% CI: 0.61 to 32.54, P=.14).
Complications and Additional Surgeries
Cumulative incidences of complications and surgeries over 5 years following lensectomy are shown in Table 2 (n=64 PFV eyes). The rate of glaucoma-related adverse events was 7% (95% CI: 0% - 20%) in pseudophakic PFV eyes and 9% (95% CI: 5% - 13%) in pseudophakic non-PFV eyes. The most common complication in aphakic eyes was glaucoma-related adverse events, estimated to develop in 24% (95% CI: 9%−37%) of PFV eyes and in 20% (95% CI: 12% - 27%) of non-PFV eyes over 5 years. The risk of glaucoma-related adverse events in aphakic participants ≤ 1 year of age at lensectomy was not significantly different in PFV vs. non-PFV eyes (age-adjusted HR=1.20, 95% CI: 0.54–2.64, P=.66).
Table 2:
Five- year Cumulative Incidence of Complications and Surgeries in Participants with Unilateral Persistent Fetal Vasculature Cataract (PFV)
| Aphakia | Pseudophakia | |||||
|---|---|---|---|---|---|---|
| Events | At riskb | 5-year incidence (95% CI)a |
Events | At riskb | 5-year incidence (95% CI)a | |
|
|
||||||
| Endophthalmitis | 0 | 48 | 0% | 0 | 16 | 0% |
| Retinal detachment | 2 | 48 | 4% (0% - 10%) | 1 | 16 | 7% (0% - 19%) |
| Visual axis opacificationc | 8 | 48 | 15% (5% - 25%) | 7 | 16 | 45% (13% - 66%) |
| Glaucoma | 9 | 47 | 21% (8% - 32%) | 0 | 16 | 0% |
| Glaucoma suspect | 1 | 47 | 4% (0% - 10%) | 1 | 16 | 7% (0% - 20%) |
| Glaucoma-related adverse events | 10 | 47 | 24% (9% - 37%) | 1 | 16 | 7% (0% - 20%) |
| Peripheral anterior synechiae | 2 | 48 | 4% (0% - 9%) | 0 | 16 | 0% |
| Iris-posterior synechiae | 4 | 48 | 9% (0% - 18%) | 2 | 16 | 13% (0% - 28%) |
| Corneal calcification | 2 | 48 | 4% (0% - 9%) | 1 | 16 | 7% (0% - 19%) |
| Persistent intraocular inflammation | 1 | 48 | 2% (0% - 6%) | 0 | 16 | 0% |
| Iris abnormalities | 5 | 48 | 11% (1% - 20%) | 0 | 16 | 0% |
| Visually-significant iris abnormalities | 0 | 48 | 0% | 0 | 16 | 0% |
| Other complications | 0 | 48 | 0% | 0 | 16 | 0% |
| Glaucoma surgery | 4 | 47 | 10% (0% - 18%) | 0 | 16 | 0% |
| Secondary IOL implantation | 5 | 48 | 13% (2% - 22%) | 0 | 16 | 0% |
| Retinal detachment surgery | 0 | 48 | 0% | 1 | 16 | 6% (0% - 18%) |
| Surgery to clear the visual axisd | 8 | 48 | 17% (5% - 27%) | 6 | 16 | 40% (9% - 60%) |
| Other surgerye | 2 | 48 | 4% (0% - 10%) | 0 | 16 | 0% |
Note. CI = confidence interval of cumulative incidence estimates. IOL = intraocular lens.
Cox proportional-hazards were used to calculate the 5-year cumulative incidence. A confidence interval is not reported when the cumulative incidence is 0%. Since the date of a complication’s onset was not collected, interval censoring was performed. Intervals were structured annually, using the visit year in which the complication was first reported to approximate individual event time, or the last year of follow-up to censor participants who did not experience the event. Only visits within 5.5 years from the date of lensectomy were used to estimate the cumulative incidence of complications. The actual surgical dates were known and were therefore used to calculate the time from lensectomy to surgery within the specified 5-year period.
One PFV eye with pre-existing glaucoma was excluded when glaucoma, glaucoma suspect, glaucoma-related adverse events, or glaucoma surgery were the outcomes. Minimum required follow-up time was 160 days after lensectomy for PFV eyes.
The cumulative incidence (95% CI) of visual axis opacity was 18% (8% - 28%) in participants who underwent anterior vitrectomy at the time of cataract surgery, and 60% (0% - 84%) without primary anterior vitrectomy.
The cumulative incidence (95% CI) of surgery to clear the axis was 19% (8% - 29%) in participants who underwent anterior vitrectomy at the time of cataract surgery, and 46% (0% - 73%) without primary anterior vitrectomy.
Descriptions of other surgeries included pupilloplasty and “iris/wound revision.”
Surgery to clear the visual axis in pseudophakic eyes had an estimated cumulative incidence of 40% (95% CI: 9%−60%) in PFV eyes and 31% (95% CI: 24% - 37%) in non-PFV eyes. The cumulative incidence (95% CI) of surgery to clear the axis was 19% (8% - 29%) in PFV eyes undergoing anterior vitrectomy at the time of cataract surgery, and 46% (0% - 73%) in PFV eyes without primary anterior vitrectomy.
There were 3 retinal detachments in PFV eyes: 2 aphakic (4%, 95% CI: 0%−10%) and 1 pseudophakic eye (7%, 95% CI: 0%−19%). There were 9 retinal detachments among 405 non-PFV eyes: 2 aphakic (2%, 95% CI: 0% - 4%) and 7 pseudophakic eyes (3%, 95% CI: 1% - 5%). Within 5 years of primary lensectomy, 5 aphakic PFV eyes (13%, 95% CI: 2% - 22%) underwent secondary IOL surgery. Persistent ocular inflammation was reported in 1 aphakic PFV eye (2%, 95% CI: 0%−6%).
Discussion
Eyes with PFV have a poor visual prognosis, especially with posterior segment disease, but there are few large studies reporting VA outcomes. In this series of 64 eyes with unilateral PFV cataract, we found that 5 years following lensectomy 48% (95% CI: 32%−64%) achieved VA better than 20/200 and 10% (4/42; 95% CI: 3% to 23%) achieved age-normal VA.
VA outcomes for unilateral aphakic eyes with PFV compare favorably with other studies of unilateral PFV cataract. Bata et al7 reported 33% of 58 aphakic eyes with PFV achieved VA better than 20/200 (6.7±4.2 years postoperatively) and Anteby et al8 reported 16.7% of 30 aphakic eyes with PFV achieved 20/200 or better (mean follow-up 8.5±6.0 years), whereas we found 59% (95% CI: 39%−76%) with aphakia following cataract surgery achieved better than 20/200. Of interest, 43% (95% CI: 32%−54%) of unilateral aphakic non-PFV eyes in our registry achieved VA better than 20/200 at 5 years.9
Outcomes in primary pseudophakic PFV eyes were less favorable with 23% (95% CI: 5%−54%) achieving VA better than 20/200, similar to Anteby et al8 (33% of 30 eyes achieving 20/200 or better; mean follow-up 3.6±3.7 years). Nevertheless, a recent study by Bata et al10 found 6 (60%) of 10 eyes with PFV and primary pseudophakia achieved better than 20/200 (follow-up ranging from 1–11.5 years). Possibly accounting for the poorer outcome in the pseudophakic eyes in our study was the observation that a greater proportion of pseudophakic eyes had posterior segment disease (6 of 13, 46%) compared with aphakic eyes (8 of 29, 28%); however, in comparing the proportions with posterior disease between pseudophakia and aphakia, the age-adjusted difference was not statistically significant, and the confidence interval for the odds ratio could not rule out a meaningful difference in either direction, most likely due to the small sample size. Older age at surgery in pseudophakic eyes may have resulted in denser amblyopia, as well as a higher rate of visual axis opacification in pseudophakic eyes which may explain their poor VA outcomes. Poor visual outcomes with combined anterior-posterior involvement in PFV have been reported in a recent study by de Saint Sauveur G, et al.11 Of 26 children with mild combined disease the mean VA was 0.2 logMAR in 16 (62%) that could be measured, 7 (27%) had light perception, and 3 (12%) had no light perception. Of 36 children with severe combined disease the mean VA was 0.08 logMAR in 7 (19%) that could be measured, 7 (19%) had light perception, and 22 (61%) had no light perception.
We found the cumulative incidence of glaucoma-related adverse events to be 24% (95% CI: 9%−37%) in aphakic PFV eyes. This is comparable with Bata et al7 who reported 35% of 40 aphakic PFV eyes with glaucoma 4.5 years postoperatively and Anteby et al8 who found glaucoma in 22.6% of 31 aphakic eyes (mean follow-up 8.5±6.0 years). By comparison, reported risks for glaucoma in unoperated PFV eyes range from 7%12 to 15%.13
There are limitations to this registry-based study including non-standardized treatment and the fact that optotype VA testing was not reported for one-third of children due to loss to follow-up or out-of-window visits. Classification of posterior PFV was based on documentation of coexisting ocular conditions documented on the annual data collection form and may have under-represented posterior segment disease. Also, when comparing PFV with non-PFV eyes for the risk of glaucoma-related adverse events in aphakic participants ≤ 1 year of age at lensectomy, the wide 95% CI on the estimate of the difference did not exclude a greater risk of glaucoma in either direction. In addition, we had a small number of pseudophakic eyes limiting analysis of outcomes in this subgroup and insufficient numbers to evaluate posterior PFV outcomes by IOL use.
In conclusion, there was a wide range of visual outcomes for PFV cataract. When comparing PFV versus non-PFV eyes, VA outcomes were similar for aphakia, but there were significantly more pseudophakic children 20/200 or worse with PFV cataract than with non-PFV cataract. There was an ongoing risk for development of glaucoma-related adverse events, but the rate was not higher in aphakic PFV eyes compared with aphakic non-PFV eyes.
Supplementary Material
Acknowledgements
a. Funding/Support:
This study was supported by the National Eye Institute of the National Institutes of Health, Department of Health and Human Services EY011751, EY023198, and EY018810. The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The study was conducted under an Investigational Device Exemption (#G110149) from the United States Food and Drug Administration.
c. Other Acknowledgements:
Desirae Sutherland had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. A list of participating sites has previously been published in JAMA Ophthalmol. 2022;140(3):269-276.
Meeting presentation:
This work was presented at the American Academy of Optometry’s Annual Meeting 2022 in San Diego, CA.
Footnotes
Financial Disclosures: No authors have any relevant conflicts of interest to disclose regarding this manuscript and all information enclosed in it.
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