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Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06115005
Enrollment
40
Registered
2023-11-02
Start date
2022-06-01
Completion date
2024-08-01
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

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

Interventions

BIOLOGICALPlasma rich in growth factors ( PRGF )

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age ≥18 years 2. 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants that revealed closure of challenging macular holes6 monthsBy clinical examination and OCT

Countries

Egypt

Contacts

Primary ContactZeyad A Askar, Assiss. lect
zeyadaskar@gmail.com01060777052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026