NCT04408807 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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
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. Epub 2004 Dec 8.
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. Epub 2006 Jul 7.

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

Clinical trial NCT04408807 - References