MedTrace Logo

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

NCT04408807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-03-24

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

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

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2020-02-04
Completion
2020-02-27

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408807 on ClinicalTrials.gov