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Final results of the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial
1Smith-Kettlewell Eye Research Institute, San Francisco, USA.
Insights
Early treatment for retinopathy of prematurity (ROP) significantly improves visual acuity and structural outcomes. This study confirms that prompt intervention for high-risk ROP is beneficial.
Area of Science:
- Ophthalmology
- Neonatal Medicine
- Pediatric Research
Background:
- Retinopathy of prematurity (ROP) is a significant cause of visual impairment in premature infants.
- High-risk prethreshold ROP requires timely management to prevent severe visual loss.
- Previous studies have investigated various treatment strategies for ROP.
Purpose of the Study:
- To present the final results of the Early Treatment for Retinopathy of Prematurity Study.
- To compare early retinal ablative treatment with conventional management for high-risk prethreshold ROP.
Main Methods:
- Infants with bilateral high-risk prethreshold ROP were randomized to early treatment or conventional management.
- Visual acuity was the primary outcome, assessed using the Teller acuity card procedure.
- Structural examinations were conducted at 6 and 9 months to evaluate outcomes.
Main Results:
- Early treatment reduced unfavorable visual acuity outcomes from 19.8% to 14.3% (P < .005).
- Unfavorable structural outcomes decreased from 15.6% to 9.0% at 9 months (P < .001).
- Specific criteria were defined for early treatment (Type I ROP) versus a 'wait and watch' approach (Type II ROP).
Conclusions:
- Early treatment of high-risk prethreshold ROP significantly reduces unfavorable visual and structural outcomes.
- The findings support the use of early retinal ablative therapy for Type I ROP.
- A 'wait and watch' approach is recommended for Type II ROP, with treatment considered upon progression.
Purpose:
To present the final results of the Early Treatment for Retinopathy of Prematurity Study.
Methods:
Infants with bilateral high-risk prethreshold retinopathy of prematurity (ROP) (n = 317) had one eye randomized to early retinal ablative treatment and the fellow eye managed conventionally (control eye). In asymmetric cases (n = 84), the eye with high-risk prethreshold ROP was randomized to early or to conventional management. High risk was determined using a model based on the Cryotherapy for Retinopathy of Prematurity natural history cohort. The primary outcome was visual acuity assessed by masked testers using the Teller acuity card procedure. Structural examinations were performed at 6 and 9 months.
Results:
Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treatment, from 19.8% to 14.3% (P < .005). Unfavorable structural outcomes were reduced from 15.6% to 9.0% (P < .001) at 9 months. Further analysis supported retinal ablative therapy for eyes with type I ROP, defined as zone I, any stage ROP with plus disease; zone I, stage 3 ROP without plus disease; or zone II, stage 2 or 3 with plus disease. The analysis supported a "wait and watch" approach to type II ROP, defined as zone I, stage 1 and 2 without plus disease, or zone II, stage 3 without plus disease. These eyes should be considered for treatment only if they progress to type I ROP or threshold.
Conclusion:
Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes in both primary and secondary (structural) measures.