Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of participants that revealed closure of challenging macular holes
Study Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Number of participants that revealed closure of challenging macular holes
Time Frame: 6 months
By clinical examination and OCT
Secondary Outcomes
No secondary outcomes reported
Investigators
Hossam Mohamed Moharram
Professor Doctor
Minia University