Dataset Information

Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.

ABSTRACT:

Purpose

To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.

Design

Prospective, randomized clinical trial.

Participants

The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract.

Intervention

Infants underwent cataract surgery with or without placement of an IOL.

Main outcome measures

The rate, character, and severity of intraoperative complications (ICs), adverse events (AEs), and additional intraocular surgeries (AISs) during the first postoperative year in the 2 groups were analyzed.

Results

There were more patients with ICs (28% vs. 11%; P = 0.031), AEs (77% vs. 25%; P<0.0001), and AISs (63% vs. 12%; P<0.0001) in the IOL group than the contact lens group. Iris prolapse was the most common IC. The most common AE was visual axis opacification, and the most common additional intraocular reoperation was a clearing of visual axis opacification.

Conclusions

The rates of ICs, AEs, and AISs 1 year after surgery were numerically higher in the IOL group, but their functional impact does not clearly favor either treatment group.

Financial disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

SUBMITTER: Plager DA

PROVIDER: S-EPMC3230731 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Publications

Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.

Plager David A DA Lynn Michael J MJ Buckley Edward G EG Wilson M Edward ME Lambert Scott R SR

Ophthalmology 20110916 12

<h4>Purpose</h4>To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.<h4>Design</h4>Prospective, randomized clinical trial.<h4>Participants</h4>The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract.<h4>Intervention</h4>Infants underwent cataract surge ...[more]

PMID: 21925737

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Project description:ImportanceGlaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia vs primary intraocular lens (IOL) implantation remains unsettled.ObjectiveTo identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study by the age of 5 years.Design, setting, and participantsA multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery. Mean follow-up was 4.8 years. This secondary analysis was conducted from December 23, 2004, to November 13, 2013.InterventionsParticipants were randomized at cataract surgery to either primary IOL or no IOL implantation (contact lens). Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis.Main outcomes and measuresDevelopment of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years, plus intraocular pressure, visual acuity, and axial length at age 5 years.ResultsProduct limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17% (95% CI, 11%-25%) and 31% (95% CI, 24%-41%), respectively. The contact lens and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio [HR], 0.8; 95% CI, 0.3-2.0; P = .62) and glaucoma + glaucoma suspect (HR, 1.3; 95% CI, 0.6-2.5; P = .58). Younger (vs older) age at surgery conferred an increased risk for glaucoma (26% vs 9%, respectively) at 4.8 years after surgery (HR, 3.2; 95% CI, 1.2-8.3), and smaller (vs larger) corneal diameter showed an increased risk for glaucoma + glaucoma suspect (HR, 2.5; 95% CI, 1.3-5.0). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (19 of 20, 95%), and 8 of 20 eyes (40%) underwent surgery.Conclusions and relevanceThese results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk. Longer follow-up of these children may further characterize risk factors, long-term outcomes, potential differences between eyes having primary IOL vs aphakia, and optimal timing of unilateral congenital cataract removal.Trial registrationclinicaltrials.gov Identifier: NCT00212134.

Project description:PurposeWe report endothelial cell (EC) characteristics and central corneal thickness (CCT) from the Infant Aphakia Treatment Study (IATS) patients at the 5-year examination.DesignRandomized, controlled trial of the treatment of unilateral cataract with aphakic contact lens (CL) versus primary intraocular lens (IOL) implant.ParticipantsA total of 114 infants with unilateral cataract.MethodsThe EC density, coefficient of variation (CV), and percent hexagonal cells were measured by noncontact specular microscopy. The CCT was measured using contact pachymetry. Fellow eyes served as controls.Main outcome measuresMean differences between treated and fellow eyes of CL and IOL groups were compared with a paired t test. A 1-way analysis of variance model and the Tukey-Kramer multiple comparison procedure were used to assess the effect of a diagnosis of glaucoma or glaucoma suspect.ResultsA total of 105 subjects (52 with CLs, 53 with IOLs) had specular microscopy or corneal thickness data recorded. Mean EC densities were higher in aphakic eyes compared with fellow eyes (3921 vs. 3495 cells/mm2, P<0.0001). Mean CV was higher (27 vs. 24, P=0.0002) and mean percent hexagonal cells was lower (72% vs. 76%, P=0.002) in aphakic eyes compared with fellow eyes. Mean CCT of aphakic eyes was higher than in controls (637 vs. 563 μm, P<0.0001). There was no difference in EC density in eyes treated with IOLs compared with fellow eyes (3445 and 3487 cells/mm2, P=0.68). Means for CV (25 vs. 24, P=0.07) and percent hexagonal cells (74 vs. 76%, P=0.27) were also not significantly different. Mean CCT was higher in eyes with IOLs (605 vs. 571 μm, P<0.0001) compared with fellow eyes. Compared with treated eyes without glaucoma or glaucoma suspect, treated eyes with glaucoma had lower EC density (3289 vs. 3783 cells/mm2, P=0.03) and treated eyes with glaucoma suspect had greater mean corneal thickness (660 vs. 612 μm, P=0.0036).ConclusionsCataract extraction during infancy with IOL implantation was not associated with a reduced EC count in treated compared with fellow eyes, although CCT was increased. Extended-wear aphakic CLs may cause corneal polymegathism with increased EC density and CCT. Glaucoma diagnosis was associated with reduced EC counts and increased CCT.

Project description:PurposeTo determine rates and risk factors associated with severe postoperative complications after cataract surgery and whether they have been changing over the past decade.DesignRetrospective longitudinal cohort study.ParticipantsA total of 221 594 Medicare beneficiaries who underwent cataract surgery during 1994-2006.MethodsBeneficiaries were stratified into 3 cohorts: those who underwent initial cataract surgery during 1994-1995, 1999-2000, or 2005-2006. One-year rates of postoperative severe adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) were determined for each cohort. Cox regression analyses determined the hazard of developing severe adverse events for each cohort with adjustment for demographic factors, ocular and medical conditions, and surgeon case-mix.Main outcome measuresTime period rates of development of severe postoperative adverse events.ResultsAmong the 221 594 individuals who underwent cataract surgery, 0.5% (1086) had at least 1 severe postoperative complication. After adjustment for confounders, individuals who underwent cataract surgery during 1994-1995 had a 21% increased hazard of being diagnosed with a severe postoperative complication (hazard ratio [HR] 1.21; 95% confidence interval [CI], 1.05-1.41) relative to individuals who underwent cataract surgery during 2005-2006. Those who underwent cataract surgery during 1999-2000 had a 20% increased hazard of experiencing a severe complication (HR 1.20; 95% CI, 1.04-1.39) relative to the 2005-2006 cohort. Risk factors associated with severe adverse events include a prior diagnosis of proliferative diabetic retinopathy (HR 1.62; 95% CI, 1.07-2.45) and cataract surgery combined with another intraocular surgical procedure on the same day (HR 2.51; 95% CI, 2.07-3.04). Individuals receiving surgery by surgeons with the case-mix least prone to developing a severe adverse event (HR 0.52; 95% CI, 0.44-0.62) had a 48% reduced hazard of a severe adverse event relative to recipients of cataract surgery performed by surgeons with the case-mix most prone to developing such outcomes.ConclusionsRates of sight-threatening adverse events after cataract surgery declined during 1994-2006. Future efforts should be directed to identifying ways to reduce severe adverse events in high-risk groups.

Dataset Information

Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.

Purpose

Design

Participants

Intervention

Main outcome measures

Results

Conclusions

Financial disclosure(s)

Publications

Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.

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