Search / Trial NCT06233500

Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study

Launched by FAYOUM UNIVERSITY · Jan 22, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Macular Hole Ilm Peeling Temporal Flap Octa Optical Coherence Tomography Angiography

Description

This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups: Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap * Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group * Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology * Data Collection : * H...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Idiopathic full thickness Macular hole without retinal detachment
  • Exclusion Criteria:
  • * Previous pars plana vitrectomy
  • * High myopia with axial length ≥ 26 mm.
  • * Uncertain symptom duration or ≥ 6 month .
  • * History of same eye trauma
  • * Poor image quality.
  • * Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.
  • * Any patient with significant cataract which needs combined phaco-vitrectomy.

About Fayoum University

Fayoum University, a prominent higher education institution in Egypt, is dedicated to advancing medical research and enhancing healthcare outcomes through innovative clinical trials. With a commitment to academic excellence and community health improvement, the university leverages its diverse expertise and state-of-the-art facilities to conduct rigorous clinical studies. By fostering collaboration among researchers, healthcare professionals, and participants, Fayoum University aims to contribute valuable insights to the medical field and promote evidence-based practices that benefit society at large.

Locations

Giza, , Egypt

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0