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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telemedicine Approaches to Evaluating Acute-phase ROP

NCT01264276

Retinopathy of Prematurity

COMPLETED

The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

NCT05099588

Retinopathy of Prematurity

COMPLETED

Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity

NCT00000133

Retinopathy of Prematurity

COMPLETED NA

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

NCT00027222

Retinopathy of Prematurity

UNKNOWN PHASE2/PHASE3

Validation of i-ROP DL to Detect More Than Mild ROP

NCT06109285

Retinopathy of Prematurity ROP

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Retinopathy of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

ROPEE screening with speculum-free fundoscopy

Group Type EXPERIMENTAL

Speculum-free (SpF) fundoscopy

Intervention Type OTHER

Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation

Control Group

ROPEE screening with speculum fundoscopy

Group Type ACTIVE_COMPARATOR

Speculum (Sp) fundoscopy

Intervention Type OTHER

Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Speculum-free (SpF) fundoscopy

Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation

Intervention Type OTHER

Speculum (Sp) fundoscopy

Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Preterm neonates undergoing screening for ROP, i.e.

* with GA \< 32weeks and/or BW \< 1501grams
* infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist

Exclusion Criteria

1. Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
2. Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
3. Neonates under sedative/analgesic treatment.
4. Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.

Minimum Eligible Age

30 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No