Clinical Trials Logo

Clinical Trial Summary

Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Approximately 90% of infants who develop ROP do so by a postmenstrual age of 46.3 weeks. In certain patients with or without treatment, the retina may fail to fully vascularize or may develop vascular abnormalities, thus demonstrating persistent avascular retina (PAR) or anomalous vessel findings at the periphery. Because of the advent of technologies such as ultrawide-field fluorescein angiography (UWFFA) persistent vascular abnormalities can be detected more readily and investigated.


Clinical Trial Description

The natural history of peripheral nonperfusion and vascular abnormalities, which persist beyond the acute phase of ROP, remains poorly understood. Although patients with a history of type I ROP (treatment requiring ROP) are more likely to exhibit abnormal foveal development and poor vision, a discrepancy still exists between the structural and functional findings of vascular abnormalities in the long term. For instance, circumferential atypical vessels are detected in patients with spontaneously regressed ROP and favorable vision. Additionally, persistent retinal vascular abnormalities may not necessarily predict adverse functional outcomes. The significance of such vessel anomalies and whether they persist or not remain uncertain. The physiologic avascular retina of children of age < 13 years usually extends ≤ 1.5 DD temporally or ≤ 1.0 DD nasally from the ora serrata. Therefore, the PAR (peripheral avascular retina) is defined as the nonperfusion area with measurements ≥ 2.0 DD, which is 3 standard deviations more than the normal value. Infants with persistent avascular retina have unknown long-term structural and functional risks, and theoretically could develop disease requiring treatment, including retinal breaks or tractional bands. Prolonged retinal traction by remnant shunt or extra-retinal fibrovascular proliferation between a stable prenatally vascularized retina in the posterior pole and an unstable postnatally vascularized retina may lead to the development of retinal holes characteristically located in the fragile, anterior undifferentiated avascular retina. Treatment options may vary from observation to retinal laser photocoagulation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06044181
Study type Interventional
Source Assiut University
Contact Alyaa Mohamed, MS
Phone 01092246445
Email alyaelkabsh686@gmail.com
Status Not yet recruiting
Phase N/A
Start date November 1, 2023
Completion date November 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT05043077 - Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening Phase 4
Completed NCT04838665 - Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study Phase 4
Completed NCT04408807 - Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided N/A
Recruiting NCT03083431 - Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity Phase 2
Enrolling by invitation NCT04985448 - Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
Recruiting NCT02090322 - Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1 N/A
Completed NCT00872664 - Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT04101721 - Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity Phase 3
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Terminated NCT01335113 - A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Active, not recruiting NCT00027222 - The Early Treatment for Retinopathy of Prematurity Study (ETROP) Phase 2/Phase 3
Recruiting NCT06109285 - Validation of i-ROP DL to Detect More Than Mild ROP N/A
Completed NCT01861470 - REDEXAM - Reducing Painful Eye Examinations in Preterm Infants N/A
Completed NCT02014454 - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature Phase 2
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Completed NCT05701124 - Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity Phase 3
Completed NCT04092127 - Pain of Premature Babies and RetCam (DOLICAM)
Completed NCT04621136 - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity Phase 1/Phase 2
Completed NCT04883931 - Mother Milk as a Eye Drop & Premature Retinopathy N/A