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Study to determine appropriate timing for infant IOL implantation
An NEI-funded multicenter trial will compare visual acuity outcomes in infants implanted with IOLs to others treated with contact lenses.
A multicenter study to determine the appropriate timing of IOL implantation in children will begin in November, according to the study’s leader.
The Infant Aphakia Treatment Study, led by Scott R. Lambert, MD, professor of ophthalmology and pediatrics at Emory University in Atlanta, will follow 96 cataract surgery patients who are randomized to receive either vision correction with an IOL or traditional management with a contact lens.
“Eventually, most of these children will get IOLs. The question is, when should implantation take place?” Dr. Lambert told Ocular Surgery News. “We plan to determine if IOL implantation in infants should be a primary procedure or a secondary procedure.”
According to Dr. Lambert, it is difficult to determine the age at which infants and children are ready for IOL implantation because of the refractive changes that occur in the first few years of life.
“It’s very hard to predict the myopic shift. This is one of the challenges of implanting an IOL with the right power at the right time,” Dr. Lambert said.
Retrospective study
A 25-patient retrospective study for IATS, which evaluated children treated with IOLs or contact lenses after 4 to 5 years of follow-up, found differences in the natural growth patterns of the eye, Dr. Lambert said.
“There is a large variation between children. It’s difficult to predict when their eyes will stop growing,” he said.
To take these natural refractive changes into account, surgeons in the study undercorrected children who were implanted with IOLs.
“We knew the eyes were going to grow, so we undercorrected children and let them wear glasses in addition to having IOLs,” Dr. Lambert said. When uncorrected visual acuity in the IOL group was compared to visual acuity in the contact lens group, researchers found similar results.
Children who were implanted with IOLs had a higher rate of secondary operations and often developed membranes across the pupil that required surgical removal.
However, Dr. Lambert said that patients with IOLs implanted in the first 6 months of life experienced a slight benefit in visual outcome.
“There seems to be a small visual advantage for the IOL group, but it was such a small benefit that we’re not sure if it really exists,” Dr. Lambert said.
IATS recruiting
The multicenter IATS study, sponsored by the National Eye Institute, will investigate the possible visual advantage of IOLs over traditional management in pediatric cataract surgery.
Investigators at 13 clinics will enroll patients younger than 7 months old who have a visually significant cataract in one eye. Patients who have a cornea less than 9 mm in diameter, glaucoma, uveitis, or retinal or optic nerve disease will be excluded from the study. Additionally, children who were born more than 4 weeks premature will also be excluded from the study.
Study outcomes will be based on visual acuity assessed by Teller acuity cards at 1 year of age, number of secondary operations required, rate of complications, myopic shift and development of strabismus. The burden of the treatment on the child’s family will also be assessed by a “parenting stress index,” which will identify which treatment is more stressful for parents to cope with based on a self-evaluating questionnaire.
Children will undergo cataract surgery and either receive a foldable acrylic IOL or be fit with an aphakic contact lens. A traveling examiner from the IATS group will assess visual acuity in all children at their first birthday.
For Your Information:
- Scott R. Lambert, MD, can be reached at the Emory Eye Center, Clinic B, 1365 Clifton Road NE, Atlanta, GA 30322; 404-778-3420; fax: 404-778-5128; e-mail: slamber@emory.edu.
- Nicole Nader is an OSN Staff Writer who covers all aspects of ophthalmology, specializing in pediatrics/strabismus and neuro-ophthalmology.