Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

NCT ID: NCT06115005

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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

Conditions

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Macular Holes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Plasma 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Mohamed Moharram

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University Hospital

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Zeyad A Askar, Assiss. lect

Role: CONTACT

01060777052

Facility Contacts

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Zeyad Askar

Role: primary

01060777052

References

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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.

Reference Type BACKGROUND
PMID: 33814043 (View on PubMed)

Arias 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.

Reference Type BACKGROUND
PMID: 31895724 (View on PubMed)

Other Identifiers

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360:2022

Identifier Type: -

Identifier Source: org_study_id

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