NCT04408807

Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 30 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation.

Detailed description

A prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a speculum and indentor. A random number table was used to allocate participants into either a) receiving Sp funduscopy on their first and SpF on their second screening examination a week later, or b) receiving SpF first and Sp a week later.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
OTHER	Speculum-free (SpF) fundoscopy	Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
OTHER	Speculum (Sp) fundoscopy	Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Timeline

• Start date: 2019-09-03
• Primary completion: 2020-02-04
• Completion: 2020-02-27
• First posted: 2020-05-29
• Last updated: 2022-03-24

Locations

1 site across 1 country: Greece