Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06115005
Other study ID # 360:2022
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2022
Est. completion date August 1, 2024

Study information

Verified date October 2023
Source Minia University
Contact Zeyad A Askar, Assiss. lect
Phone 01060777052
Email zeyadaskar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes


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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
Egypt Minia University Hospital Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants that revealed closure of challenging macular holes By clinical examination and OCT 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT04535622 - Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery N/A
Completed NCT03572725 - Air Tamponade and Non-supine Positioning in Macular Hole Surgery. N/A
Completed NCT01471912 - Elongation of Foveal Tissue After Macular Hole Surgery N/A
Completed NCT03646695 - ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study N/A
Completed NCT06323902 - Autologous Platelet-rich Plasma as a Treatment for Macular Holes
Completed NCT01974310 - Postoperative Positioning After Surgery for Macular Holes N/A
Completed NCT00537992 - Blue-Blocking IOLs in Combined Surgery N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Recruiting NCT06000111 - Duration of Face Down Positioning for Full-Thickness Macular Hole Repair N/A
Recruiting NCT04135638 - Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison N/A
Completed NCT03525899 - Macular Hole After Diabetic Vitrectomy
Completed NCT03917602 - Human Amniotic Membrane Plug for Large Macular Holes N/A
Completed NCT04527848 - Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery Phase 4
Recruiting NCT04116892 - Comparative Analysis of Large Macular Hole Surgeries N/A
Completed NCT01229657 - Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes N/A
Completed NCT01381965 - Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery N/A
Completed NCT01306487 - Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery N/A
Completed NCT03174639 - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps N/A
Recruiting NCT05083650 - Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis N/A