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Multicenter trial of early treatment for retinopathy of prematurity: study design
Insights
Early intervention for retinopathy of prematurity (ROP) in high-risk infants improves visual acuity. The Early Treatment for Retinopathy of Prematurity (ETROP) study demonstrated better outcomes with timely retinal ablation.
Area of Science:
- Ophthalmology
- Neonatal Medicine
- Clinical Trials
Background:
- Retinopathy of prematurity (ROP) is a leading cause of vision loss in premature infants.
- Moderate to severe ROP requires timely management to prevent adverse outcomes.
- The Early Treatment for Retinopathy of Prematurity (ETROP) study addressed the optimal timing for intervention.
Purpose of the Study:
- To compare the safety and efficacy of early vs. conventional timing of peripheral retinal ablation for moderate to severe ROP.
- To describe the unique risk analysis model (RM-ROP2) used for selecting high-risk prethreshold ROP eyes for randomization.
- To evaluate the impact of early treatment on visual acuity and retinal structure in infants with ROP.
Main Methods:
- A prospective, randomized, multicenter trial involving 401 infants with ROP.
- Screening of ~7000 infants with birth weights <1251 g.
- Utilized the RM-ROP2 risk model to select prethreshold ROP eyes at high risk for adverse outcomes.
- Primary outcome: grating visual acuity at 9 months post-term; Secondary outcome: retinal structure at 6 and 9 months post-term.
Main Results:
- Early intervention in selected high-risk prethreshold ROP eyes resulted in improved grating visual acuity.
- Categorization of visual acuity into favorable (>or=1.85 cycles/degree) and unfavorable (<1.85 cycles/degree) outcomes.
- Assessment of retinal structure provided secondary outcome data.
Conclusions:
- Early treatment for selected high-risk prethreshold retinopathy of prematurity eyes leads to improved vision.
- The ETROP study highlights the importance of risk stratification in managing ROP.
- Timely intervention in ROP can significantly enhance visual outcomes in premature infants.
Abstract:
The Early Treatment for Retinopathy of Prematurity (ETROP) study was a randomized, prospective multicenter trial comparing the safety and efficacy of earlier vs. conventionally timed ablation of the peripheral retina for the management of moderate to severe retinopathy of prematurity (ROP). Approximately 7000 infants with birth weights <1251 g were screened at 26 centers over a 2-year period to achieve the sample size of 401 consented infants for the randomized trial. In order to minimize treatment of eyes with ROP that were likely to undergo spontaneous regression of the disease, a risk analysis model, RM-ROP2, was used to select for inclusion in the randomized trial only prethreshold eyes that had a high risk of an adverse outcome. The primary outcome measure was grating visual acuity measured by Teller acuity card testing conducted by masked testers in eyes randomized to earlier treatment vs. eyes randomized to conventional management when infants were 9 months post-term. Results were categorized into favorable (>or=1.85 cycles/degree) vs. unfavorable (<1.85 cycles/degree). The secondary outcome measure was retinal structure, assessed by ophthalmological examinations conducted at 6 and 9 months post-term. Here we describe a unique approach used in the ETROP study to select high-risk prethreshold ROP eyes for randomization and details about design of the study. Study results indicated that earlier intervention in selected high-risk prethreshold eyes results in improved vision in premature infants with ROP.