Peripheral Avascular Retina in Retinopathy of Prematurity

May 9, 2024 updated by: Alyaa mohamed yousef ahmed elkabsh, Assiut University

Long Term Management of Peripheral Avascular Retina in Retinopathy of Prematurity Evaluated by Fundus Fluorescein Angiography.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 088
        • Recruiting
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with persistent peripheral avascular retina attending follow up till the age of 18 months in the core study whether;
  • regressed ROP: children with regressed ROP who had not received any treatment.
  • IVI treatment ROP: children with a history of threshold ROP treated with IVI of anti-VEGF agents.

Exclusion Criteria:

  • Eyes with previous laser therapy.
  • Eyes with any other pathology, other than ROP.
  • Eyes with stage 4 or 5 ROP.
  • Patients with hypersensitivity to iodinated contrast media, liver and renal insufficiency, history of asthma.
  • Patients who will show hypersensitivity reaction to fluorescein angiography will be excluded from the thesis.
  • Patients unfit for general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Peripheral avascular retina of ROP with no leakage.
If there is no active leakage detected by FFA, patients would be observed. The follow-up period: FFA will be done at the age of 18 months we will repeat FFA every 6 months and fundus examination with color photography every 3 months till the age of 3 years of children.
Active Comparator: Peripheral avascular retina of ROP with active leakage.
If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route.
Procedure: Diode laser photocoagulation.
If there is evidence of active leakage by FFA The confluent laser burns will be applied to the entire avascular retina from the ridge to the ora serrata for 360 through the transpupillary route. The laser settings used are: power 250-400 mW and duration of 200-400 ms for 810 nm DLPC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of eyes showing peripheral retinal active leakage.
Time Frame: 18 months
Management of active leakage by laser ablation.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Avascular Retina in ROP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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