Serious Complications Uncommon After Primary Lens Implantation in Children

A third of intraocular lens (IOL) implants for nontraumatic glaucoma in children required reoperation for visual axis opacification (VAO) within 5 years, most often in eyes that did not have anterior vitrectomy, a large cohort study showed.

Overall, 32% of 609 eyes developed VAO requiring reoperation after primary IOL implantation. The reoperation rate for VAO was 58% without anterior vitrectomy at the time of IOL implantation versus 12% with anterior vitrectomy. The incidence of reoperation for VAO did not differ significantly by age after adjustment for anterior vitrectomy.

Patients had a modest but clinically significant risk of glaucoma 5 years after surgery, which also did not differ by age, reported Kimberly G. Yen, MD, of the Jaeb Center for Health Research in Tampa, Florida, and co-authors from the Pediatric Eye Disease Investigator Group (PEDIG).

“Despite concern that additional complications associated with cataract surgery might occur in children with primary IOL implantation, there was a low cumulative risk of serious complications, including retinal detachment and endophthalmitis 5 years after lensectomy,” the authors wrote in JAMA Ophthalmology.

“The risk of glaucoma development across all ages at surgery suggests a need for long-term monitoring,” they added.

The findings have substantial implications for clinical practice, particularly the findings related to VAO reoperation and subsequent glaucoma development, according to the author of an accompanying editorial.

“Presumably the complication of visual axis opacification after IOL implantation may be related to the proliferation of lens epithelial cells, with anterior vitrectomy possibly reducing that risk,” wrote Yizhi Liu, MD, PhD, of Sun Yat-Sen University in Guangzhou, China. “Visual axis opacity after IOL implantation was not associated with age at surgery or IOL location, but there was a 7% incidence of glaucoma, or becoming a glaucoma suspect, at 5 years. These study results suggest that long-term follow-up is necessary.”

“These data are immediately useful to children (and their parents or guardians) who are considering cataract surgery, as well as to the pediatric ophthalmologists who are monitoring these children for complications after cataract surgery,” he added. “Hopefully, PEDIG will continue their research efforts in this area.”

Primary IOL implantation has become increasingly common for older children, despite lack of FDA approval for use of the implants in children, Yen and co-authors noted. As a result, there is limited data regarding long-term outcomes after IOL implantation in children.

PEDIG investigators sought to fill some of the data void by describing the type and frequency of complications occurring in the first 5 years after primary IOL implantation. The PEDIG database contains information on children 2 years or older with pseudophakia.

Data for the current study included 491 children younger than 13 treated at 61 academic and community-based practices from June 2012 to July 2015. All the children had primary IOL implantation (345 bilateral, 264 unilateral) for nontraumatic cataract and no history of glaucoma. The primary outcomes were 5-year cumulative incidence of complications assessed by age at surgery and by IOL location (sulcus vs capsular bag).

The patients had a mean age of 5.6 years, and boys accounted for 53% of the study population.

The results showed that reoperation for VAO was the most common complication occurring within 5 years of surgery. The risk of reoperation for VAO was more than six times higher when anterior vitrectomy was not performed at the time of IOL implantation (HR 6.19, 95% CI 3.70-10.34, P<0.001).

The authors acknowledged several limitations of the study: small number of patients younger than age 1, precluding generalizability to that age group; anterior vitrectomy at surgeon’s discretion; use of a single IOL design from a single manufacturer for most procedures; wide confidence intervals for some analyses, suggesting that large and clinically meaningful differences could not be ruled out.

Analysis by age group (<2, 2 to <4, or 4 to <7) showed no significant difference in the cumulative incidence of reoperation for VAO (P=0.74). Results also did not differ by capsular bag or sulcus IOL fixation (HR 1.22, 95% CI 0.36-4.17).

The data showed low 5-year rates for other types of complications, including corneal calcification (3%), retinal detachment (2%), peripheral anterior synechiae (<1%), posterior synechiae (1%), persistent intraocular inflammation (1%), surgically caused iris abnormalities (3%), endophthalmitis (<1%), and all others (1%).