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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | ROPEE screening with speculum-free fundoscopy |
|
| Control Group | Active Comparator | ROPEE screening with speculum fundoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speculum-free (SpF) fundoscopy | Other | Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Premature Infant Pain Profile-Revised score (PIPP) | 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)] |
| Measure | Description | Time Frame |
|---|---|---|
| Crying score of the Bernese pain scale | During the examination | |
| Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance | During the examination and during the 24 hours after the examination |
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Inclusion Criteria:
Preterm neonates undergoing screening for ROP, i.e.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Papageorgiou" Hospital | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19815939 | Background | Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8. | |
| 16828505 |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D059405 | Sun Protection Factor |
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011874 | Radiometry |
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| Speculum (Sp) fundoscopy | Other | Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation |
|
| Adequacy of judging the presence of treatment-requiring ROP | At the end of ROPEE screening |
| Duration of fundoscopy | During the examination |
| Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7. |
| 15814220 | Background | Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8. |
| 8120743 | Background | Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08. |
| 34939742 | Result | Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013523 |
| Surgical Equipment |
| D004864 | Equipment and Supplies |