A Randomized Clinical Trial Comparing Contact Lens With Intraocular Lens Correction of Monocular Aphakia During Infancy

Lambert,; Eg, Buckley; Drews‐Botsch, Carolyn; DuBois, Lindreth; Ee, Hartmann; Mj, Lynn; Da, Plager; Me, Wilson

doi:10.1001/archophthalmol.2010.101

Cited by 149 publications

(69 citation statements)

References 30 publications

(34 reference statements)

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“…It has been reported that 58 of the 114 IATS patients (50.9%) developed an adverse event (AE) in the first year following cataract surgery. 11 Among the patients with one or more adverse event, 30/48 (63%) had strabismus compared with 22/38 (58%) in the patients without an adverse event (p=0.82).…”

Section: Resultsmentioning

confidence: 91%

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One-Year Strabismus Outcomes in the Infant Aphakia Treatment Study

et al. 2013

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Objective To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation. Design Secondary outcome analysis in a 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 a unilateral congenital cataract. Intervention Infants underwent cataract surgery with or without placement of an IOL. Main Outcome Measures The proportion of patients who developed strabismus during the first 12 months of follow-up was calculated using the life-table method, and compared across treatment groups and age strata using a log-rank test. Results Strabismus developed within the first 12 months of follow-up in 38 (life table estimate: 66.7%) pseudophakic infants and 42 (life table estimate: 74.5%) infants treated with contact lenses (p=0.59). The younger cohort (< 49 days) at the time of surgery developed less strabismus (29 of 50, life table estimate: 58.0%) than the older cohort (≥ 49 days) (51 of 64, life table estimate: 80.0%) (p<0.01). Conclusions Intraocular lens placement does not prevent the early development of strabismus following congenital cataract surgery. However, strabismus was less likely to develop in infants whose cataract was removed at an earlier age.

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Section: Resultsmentioning

confidence: 91%

“…The primary outcomes at one year after cataract surgery including visual acuity, adverse events, and additional surgeries have been previously described. 11 In this report we compare the timing of onset and characteristics of strabismus between the two treatment cohorts up to one year postoperatively.…”

Section: Introductionmentioning

confidence: 99%

One-Year Strabismus Outcomes in the Infant Aphakia Treatment Study

et al. 2013

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“…The Infant Aphakia Treatment Study was a multi-center, randomized, controlled clinical trial sponsored by the National Eye Institute to determine whether primary IOL implantation in infants younger than 7 months of age with a unilateral congenital cataract results in improved visual outcomes over contact lens correction of aphakia. 1,2 Half of the 114 infants enrolled in this multicenter study were randomized to receive an IOL with a lens power determined using the Holladay 1 formula. The mean absolute prediction error was 1.8 ± 1.3 diopters (D), with greater error noted in eyes with shorter globe axial length (AL).…”

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confidence: 99%

Predictability of Intraocular Lens Power Calculation Formulae in Infantile Eyes With Unilateral Congenital Cataract: Results from the Infant Aphakia Treatment Study

VanderVeen

Trivedi

Nizam

et al. 2013

American Journal of Ophthalmology

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PURPOSE To compare accuracy of intraocular lens (IOL) power calculation formulae in infantile eyes with primary IOL implantation. DESIGN Comparative case series. METHODS The Hoffer Q, Holladay 1, Holladay 2, Sanders-Retzlaff-Kraff (SRK) II, and Sanders-Retzlaff-Kraff theoretic (SRK/T) formulae were used to calculate predicted postoperative refraction for eyes that received primary IOL implantation in the Infant Aphakia Treatment Study. The protocol targeted postoperative hyperopia of +6.0 or +8.0 diopters (D). Eyes were excluded for invalid biometry, lack of refractive data at the specified postoperative visit, diagnosis of glaucoma or suspected glaucoma, or sulcus IOL placement. Actual refraction 1 month after surgery was converted to spherical equivalent and prediction error (predicted refraction – actual refraction) was calculated. Baseline characteristics were analyzed for effect on prediction error for each formula. The main outcome measure was absolute prediction error. RESULTS Forty-three eyes were studied; mean axial length was 18.1 ± 1.1 mm (in 23 eyes, it was <18.0 mm). Average age at surgery was 2.5 ± 1.5 months. Holladay 1 showed the lowest median absolute prediction error (1.2 D); a paired comparison of medians showed clinically similar results using the Holladay 1 and SRK/T formulae (median difference, 0.3 D). Comparison of the mean absolute prediction error showed the lowest values using the SRK/T formula (1.4 ± 1.1 D), followed by the Holladay 1 formula (1.7 ± 1.3 D). Calculations with an optimized constant showed the lowest values and no significant difference between the Holladay 1 and SRK/T formulae (median difference, 0.3 D). Eyes with globe AL of less than 18 mm had the largest mean and median prediction error and absolute prediction error, regardless of the formula used. CONCLUSIONS The Holladay 1 and SRK/T formulae gave equally good results and had the best predictive value for infant eyes.

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“…This is one of the reasons cited for considering primary IOL implantation during infancy despite the higher rate of adverse events and additional intraocular surgeries associated with IOL implantation in this age group. 3 The high success rate of contact lens wear following congenital cataract surgery in countries with socialized health care systems suggests that cost is an important factor when treating children with aphakic contact lenses. 15,18 The IATS provides further evidence that when the economic burden of contact lens use is removed from caregivers that excellent contact lens adherence can be achieved.…”

Section: Discussionmentioning

confidence: 99%

“…2–4 Therefore, we recommended that infants undergoing surgery for a unilateral cataract during the first 6 months of life be left aphakic and be optically corrected with a contact lens. 3 …”

Section: Introductionmentioning

confidence: 99%

Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study

et al. 2018

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IMPORTANCE Although contact lenses have been used for decades to optically correct eyes in children after cataract surgery, there has never been a prospective study looking at contact lens adherence in children with aphakia, to our knowledge. OBJECTIVE To evaluate contact lens adherence and its association with visual outcome in a cohort of children treated for unilateral cataract surgery.DESIGN, SETTING, AND PARTICIPANTS Secondary analysis of a multicenter randomized clinical trial of 57 infants born from August 22, 2004, to April 25, 2008, who were randomized to 1 of 2 treatments and followed up to age 5 years. Data analysis was performed from August 9, 2016, to December 7, 2017. INTERVENTIONS Unilateral cataract extraction and randomization to implantation of an intraocular lens vs contact lens to correct aphakia.MAIN OUTCOMES AND MEASURES Contact lens adherence was assessed by a 48-hour recall telephone interview that was administered every 3 months starting 3 months after surgery to age 5 years. A traveling examiner assessed visual acuity in patients at aged 4.5 years. Adherence to prescribed contact lens use was estimated as the mean percentage of waking hours as reported in 2 or more interviews for each year of life. RESULTSOf 57 infants who were randomized to contact lens treatment, 32 (56%) were girls, and 49 (86%) were white. A total of 872 telephone interviews were completed. In year 1, a median of 95% participants wore their contacts lenses nearly all waking hours (interquartile range [IQR], 84%-100%); year 2, 93% (IQR, 85%-99%); year 3, 93% (IQR, 85%-99%); year 4, 93% (IQR, 75%-99%); and year 5, 89% (IQR, 71%-97%). There was a tendency for poorer reported adherence at older ages (F = 3.86, P < .001). No differences were identified when the results were analyzed by sex, insurance coverage, or age at cataract surgery. Using linear regression, children who wore the contact lens for a greater proportion of waking hours during the entire study period tended to have better visual acuity at age 4.5 years, even after accounting for adherence to patching (partial correlation = -0.026; P = .08). CONCLUSIONS AND RELEVANCEThese results confirm that it is possible to achieve a high level of aphakic contact lens adherence over a 5-year period in children. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00212134

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A Randomized Clinical Trial Comparing Contact Lens With Intraocular Lens Correction of Monocular Aphakia During Infancy

Cited by 149 publications

References 30 publications

One-Year Strabismus Outcomes in the Infant Aphakia Treatment Study

One-Year Strabismus Outcomes in the Infant Aphakia Treatment Study

Predictability of Intraocular Lens Power Calculation Formulae in Infantile Eyes With Unilateral Congenital Cataract: Results from the Infant Aphakia Treatment Study

Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study

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