Plasma rich in growth factors ( PRGF ) in Macular Holes - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Macular Holes

Intervention / Treatment

Biological: Plasma rich in growth factors ( PRGF )

Detailed Description

Challenging full thickness macular holes ( FTMH) include :

Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes.

This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Study Type

Interventional

Enrollment (Estimated)

40

Phase

Phase 2

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

Name: Zeyad A Askar, Assiss. lect
Phone Number: 01060777052
Email: zeyadaskar@gmail.com

Study Locations

Egypt
- - Minya, Egypt
    - Recruiting
    - Minia University Hospital
    - Contact:
      
      Zeyad Askar
      
      Phone Number: 01060777052

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

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age ≥18 years
Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm

Exclusion Criteria:

1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH

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: N/A
Interventional Model: Single Group Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that revealed closure of challenging macular holes Time Frame: 6 months	By clinical examination and OCT	6 months

Collaborators and Investigators

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

Sponsor

Minia 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)

June 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)