Purpose

To study the safety and efficacy of indirect ophthalmoscopy with (Sp) or without (speculum free, SpF) the use of lid speculum and scleral indentation for retinopathy of prematurity (ROP) screening.

Methods

In this crossover randomized controlled trial, preterm infants received either the Sp on their first and the SpF technique on their second examination a week later or vice versa. Video recordings of the infants’ reactions were assessed by two observers, using Premature Infant Pain Profile–Revised score and the crying score of the Bernese Pain Scale for Neonates. Fundoscopy adequacy, its duration and adverse events within the first 24 hr postscreening were also recorded.

Results

Thirty-seven infants with median (interquartile range) gestational age of 28.7 (28.0, 30.2) weeks and mean (standard deviation, SD) birth weight 1225 (377) grams were enrolled. The mydriasis-induced stress was similar between the Sp and SpF exam (mean difference [MD]: 0.78, 95% confidence interval [CI]: −0.83, 2.38; p = 0.33). The stress induced by fundoscopy (MD: 4.98, 95% CI: 3.58, 6.37; p < 0.001) and examination overall (MD: 2.32, 95% CI: 0.96, 3.67; p = 0.001) were higher in the Sp than in the SpF exam, and so was the crying score during fundoscopy (MD: 1.31, 95% CI: 1.06, 1.56; p < 0.001). Adverse events in the two groups were similar (p = 0.13). Fundoscopy was adequate in identifying the absence of treatment-requiring ROP in all cases, and lasted longer in the Sp than in the SpF exam (p < 0.001).

Conclusion

Our study suggests that the use of speculum and indentation should be reserved for the few cases where fundus visualization is insufficient for excluding the presence of severe ROP.