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The Early Treatment for Retinopathy Of Prematurity Study: structural findings at age 2 years
1Smith-Kettlewell Eye Research Institute, 2318 Fillmore Street, San Francisco, CA 94115, USA. good@ski.org
Insights
Early treatment for high-risk retinopathy of prematurity (ROP) significantly improves long-term retinal structure outcomes. This intervention reduces unfavorable structural outcomes by age two without increasing known side effects.
Area of Science:
- Ophthalmology
- Neonatal Medicine
- Retinal Diseases
Background:
- Retinopathy of prematurity (ROP) is a significant cause of visual impairment in premature infants.
- High-risk, prethreshold ROP requires timely intervention to prevent severe visual loss.
- Optimal timing for ROP treatment remains a critical clinical question.
Purpose of the Study:
- To evaluate the long-term structural outcomes of earlier treatment for high-risk, prethreshold retinopathy of prematurity (ROP).
- To compare retinal structural results at 2 years of age between early intervention and conventional management of ROP.
Main Methods:
- A randomized controlled trial involving infants with bilateral high-risk, prethreshold ROP.
- One eye was randomly assigned to early peripheral retinal ablation; the fellow eye received conventional management.
- Structural outcomes were assessed at 2 years of age, defining unfavorable outcomes as macular involvement by retinal folds, detachment, or retrolental tissue.
Main Results:
- Unfavorable structural outcomes were significantly reduced in eyes treated earlier (9.1%) compared to conventionally managed eyes (15.4%) at 2 years (p = 0.002).
- Data were available for 90.6% of surviving children, confirming the robustness of the findings.
- Ophthalmic side effects, excluding retinal structure, were comparable between early and conventional treatment groups.
Conclusions:
- Early treatment of high-risk, prethreshold ROP provides enduring benefits for retinal structure up to 2 years of age.
- The positive structural outcomes from early intervention are not offset by increased side effects.
- Earlier treatment enhances the likelihood of favorable long-term retinal structural outcomes in ROP.
Objective:
To determine whether earlier treatment of high-risk, prethreshold retinopathy of prematurity (ROP) improves retinal structural outcome at 2 years of age.
Methods:
Infants with bilateral high-risk prethreshold ROP had one eye randomly assigned to treatment with peripheral retinal ablation. The fellow eye was managed conventionally, and either treated at threshold ROP or observed if threshold was never reached. In patients with asymmetrical disease, the high-risk, prethreshold eye was randomised to earlier treatment or to conventional management. At 2 years of age, children were examined comprehensively by certified ophthalmologists to determine structural outcomes for their eyes. For the purposes of this study, an unfavourable structural outcome was defined as (1) a posterior retinal fold involving the macula, (2) a retinal detachment involving the macula or (3) retrolental tissue or "mass" obscuring the view of the posterior pole. Results of the 2-year examination were compared with those from the 9 months examination.
Results:
Data were available on 339 of 374 (90.6%) surviving children. Unfavourable structural outcomes were reduced from 15.4% in conventionally managed eyes to 9.1% in earlier-treated eyes (p = 0.002) at 2 years of age. Ophthalmic side effects (excluding retinal structure) from the ROP or its treatment were similar in the earlier-treated eyes and the conventionally managed eyes.
Conclusion:
The benefit of earlier treatment of high-risk prethreshold ROP on retinal structure endures to 2 years of age, and is not counterbalanced by any known side effect caused by earlier intervention. Earlier treatment improves the chance for long-term favourable retinal structural outcome in eyes with high-risk prethreshold ROP. Long-term follow-up is planned to determine structural and functional outcomes at 6 years of age.
