Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
1 other identifier
interventional
40
1 country
1
Brief Summary
Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 26, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedNovember 2, 2023
October 1, 2023
1.6 years
August 26, 2023
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants that revealed closure of challenging macular holes
By clinical examination and OCT
6 months
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia University Hospital
Minya, Egypt
Related Publications (2)
Mahmoud TH, Thompson JT. The Treatment of Difficult Macular Holes. Ophthalmol Retina. 2021 Apr;5(4):315-316. doi: 10.1016/j.oret.2021.02.002. No abstract available.
PMID: 33814043BACKGROUNDArias JD, Hoyos AT, Alcantara B, Sanchez-Avila RM, Arango FJ, Galvis V. PLASMA RICH IN GROWTH FACTORS FOR PERSISTENT MACULAR HOLE: A PILOT STUDY. Retin Cases Brief Rep. 2022 Mar 1;16(2):155-160. doi: 10.1097/ICB.0000000000000957.
PMID: 31895724BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
August 26, 2023
First Posted
November 2, 2023
Study Start
June 1, 2022
Primary Completion
December 31, 2023
Study Completion
August 1, 2024
Last Updated
November 2, 2023
Record last verified: 2023-10