Clinical trial NCT06233500: Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
Official title: Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Holes
Keywords: macular hole
ILM peeling
Temporal flap
OCTA
Optical Coherence Tomography Angiography
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Research Institute of Ophthalmology, Egypt
First posted: 2024-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will include 28 eyes with idiopathic full thickness macular hole; All eyes in this study will be subjected to pars plana vitrectomy procedure, they will be divided into two groups:

Group A: 16 eyes will be treated with only wide internal limiting membrane (ILM) peeling up to the arcades without ILM flap Group B : 16 eyes will be treated by ILM peeling with ILM flap.
Primary purpose: TREATMENT

Brief summary: The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.

The main questions it aims to answer are:

* What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
* Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
* What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.

Participants will be:

* Subjected to pars plana vitrectomy to repair macular hole.
* Examined by optical coherence tomography angiography pre and post operative

Researchers will compare:

Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.

Detailed 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 :

  * History :

    1. Demographic data ( age , gender )
    2. General medical history ( DM, HTN )
    3. Symptom duration
    4. Previous ocular history
  * Clinical examination:

    1. Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).
    2. Slit lamp biomicroscopy for anterior segment examination.
    3. Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
    4. Axial length measurement
  * Optical Coherence Tomography:

We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.

* Surgical Procedure

All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:

* 23 G trocar system will be used
* Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
* Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling

Patients will be divided then into two groups:

Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done

* Shaving of the vitreous base, and then fluid air exchange
* SF 6 gas tamponade will be used

  • Study procedures:

  o Regular clinical assessment pre and at 1 and 6 months post-operative including:
* Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
* Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)

  * Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:

Macula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.

o Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone.

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.

Primary outcomes:
measure: visual acuity
timeFrame: It will be measured preoperative and at 1 and 6 months post-operative
measure: Fovea avascular zone FAZ
timeFrame: It will be measured preoperative and at 1 and 6 months post-operative
Secondary outcomes:
measure: central retinal thickness
timeFrame: It will be measured preoperative and at 1 and 6 months post-operative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: research institute of ophthalmology, Egypt
Study officials:
affiliation: Research Institute of Ophthalmology, Egypt
name: Islam Mohalhal, MD
role: STUDY_DIRECTOR
References:
citation: Demirel S, Degirmenci MFK, Bilici S, Yanik O, Batioglu F, Ozmert E, Alp N. The Recovery of Microvascular Status Evaluated by Optical Coherence Tomography Angiography in Patients after Successful Macular Hole Surgery. Ophthalmic Res. 2018;59(1):53-57. doi: 10.1159/000484092. Epub 2017 Nov 29.
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citation: Casini G, Mura M, Figus M, Loiudice P, Peiretti E, De Cilla S, Fuentes T, Nasini F. INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR MACULAR HOLE SURGERY WITHOUT EXTRA MANIPULATION OF THE FLAP. Retina. 2017 Nov;37(11):2138-2144. doi: 10.1097/IAE.0000000000001470.
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