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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
37
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
"Papageorgiou" Hospital
Thessaloniki, Greece
Premature Infant Pain Profile-Revised score (PIPP)
Time frame: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]
Crying score of the Bernese pain scale
Time frame: During the examination
Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
Time frame: During the examination and during the 24 hours after the examination
Adequacy of judging the presence of treatment-requiring ROP
Time frame: At the end of ROPEE screening
Duration of fundoscopy
Time frame: During the examination
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