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Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.

ABSTRACT: To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study, a study of patients with monocular infantile cataracts.We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age. All infants underwent cataract surgery between 1 and 7 months of age. Monocular acuity was assessed at 4.5 years of age by a traveling examiner using the Amblyopia Treatment Study HOTV protocol.Age at cataract surgery was weakly associated with visual acuity (Spearman rank correlation coefficient = 0.19, P = 0.041) with median visual acuity better among the younger patients (28-48 days: 0.50 logMAR, 49-210 days: 1.10 logMAR, P = 0.046). Patients from families with private insurance had significantly better median visual acuity (0.60 vs. 1.40 logMAR, P = 0.0004). No other baseline characteristic revealed a significant bivariate relationship with visual acuity. A multiple linear regression relating visual acuity to all baseline characteristics demonstrated that only the availability of private insurance was statistically significant, accounting for 12% of the variance.This analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts. The fact that only one baseline variable (private insurance) contributed to the multivariate analysis, accounting for 12% of the variance, suggests that predicting visual outcome for these patients is complicated at best, and cannot be estimated from baseline characteristics alone. (ClinicalTrials.gov number, NCT00212134.).

SUBMITTER: Hartmann EE

PROVIDER: S-EPMC4296771 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.

Hartmann E Eugenie EE Lynn Michael J MJ Lambert Scott R SR

Investigative ophthalmology & visual science 20141211 1

<h4>Purpose</h4>To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study, a study of patients with monocular infantile cataracts.<h4>Methods</h4>We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age. All infants underwent cataract surgery between 1 and 7 months of age. Monocular acuity was asse ...[more]

PMID: 25503455

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Project description:ImportanceThe efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown.ObjectiveTo compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy.Design, setting, and participantsThe Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years.InterventionsCataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment.Main outcomes and measuresHOTV optotype visual acuity at 4.5 years of age.ResultsThe median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group (P = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P < .001).Conclusions and relevanceThere was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia.Trial registrationclinicaltrials.gov Identifier: NCT00212134

Project description:PurposeTo report the longitudinal change in axial length (AL) from the time of unilateral cataract surgery at age 1 to 7 months to age 5 years, and to compare AL growth of operated eyes with that of fellow unoperated eyes.DesignComparative case series.ParticipantsInfants enrolled in the Infant Aphakia Treatment Study (IATS).MethodsThe AL at baseline and age 5 years and change in AL were analyzed relative to treated versus fellow eye, visual outcome, and treatment modality (contact lens [CL] vs. intraocular lens [IOL]). Eyes with glaucoma or glaucoma suspect were excluded from primary analysis but reported separately.Main outcome measuresThe AL growth from preoperative to age 5 years.ResultsSeventy patients were eligible; however, AL data for both eyes were available for 64 patients at baseline and 69 patients at age 5 years. The AL was significantly different between treated and fellow eyes preoperatively (18.1 vs. 18.7 mm, P < 0.0001) and at the final follow-up (21.4 vs. 22.1 mm, P = 0.0004). The difference in AL growth between treated and fellow eyes was not significant (3.3 vs. 3.5 mm, P = 0.31). The change in AL in eyes was similar with both treatments (CL 3.2 mm and IOL 3.4 mm, P = 0.53) and did not correlate with visual outcomes (P = 0.85). Eyes receiving additional surgery to clear the visual axis opacification grew significantly more compared with eyes not receiving surgery to clear the visual axis (3.8 vs. 2.7 mm, P = 0.013). Patients with glaucoma showed significantly more eye growth (5.7 mm) than those without glaucoma (3.3 mm) and glaucoma suspects (4.3 mm).ConclusionsEyes treated for monocular cataract in infancy have axial growth similar to that of fellow eyes, despite having a shorter AL at the time of surgery. The change in AL in eyes was similar with both treatments (CL and IOL), did not correlate with visual outcomes, and was higher in eyes receiving additional surgery to clear the visual axis or eyes diagnosed with glaucoma.

Dataset Information

Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.

Publications

Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.

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