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

NCT06233500 | Unknown

• 1 other identifier: FayoumU_28
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

macular hole; ILM peeling; Temporal flap; OCTA; Optical Coherence Tomography Angiography

Outcome Measures

Primary Outcomes (2)

• visual acuity

  Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis

  It will be measured preoperative and at 1 and 6 months post-operative

• Fovea avascular zone FAZ

  Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)

  It will be measured preoperative and at 1 and 6 months post-operative

Secondary Outcomes (1)

• central retinal thickness

  It will be measured preoperative and at 1 and 6 months post-operative

Study Arms (2)

Group A: eyes will be treated without ILM flap

ACTIVE COMPARATOR

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

Procedure: pars plana vitrectomy

Group B : eyes will be treated by ILM flap

ACTIVE COMPARATOR

Group B: ILM peeling with flap well be done

Procedure: pars plana vitrectomy

Interventions

pars plana vitrectomy 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

Also known as: PPV with ILM peeling

Group A: eyes will be treated without ILM flap; Group B : eyes will be treated by ILM flap

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic full thickness Macular hole without retinal detachment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead
• Research Institute of Ophthalmology, Egypt: collaborator

Study Sites (1)

research institute of ophthalmology, Egypt

Giza, 12511, Egypt

RECRUITING

Related Publications (11)

• 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.

  PMID: 29183023 BACKGROUND

• Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.

  PMID: 2025167 BACKGROUND

• Lai MM, Williams GA. Anatomical and visual outcomes of idiopathic macular hole surgery with internal limiting membrane removal using low-concentration indocyanine green. Retina. 2007 Apr-May;27(4):477-82. doi: 10.1097/01.iae.0000247166.11120.21.

  PMID: 17420702 BACKGROUND

• 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.

  PMID: 28129215 BACKGROUND

• Yun C, Ahn J, Kim M, Kim JT, Hwang SY, Kim SW, Oh J. Characteristics of retinal vessels in surgically closed macular hole: an optical coherence tomography angiography study. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1923-1934. doi: 10.1007/s00417-017-3742-6. Epub 2017 Jul 25.

  PMID: 28744658 BACKGROUND

• Woon WH, Greig D, Savage MD, Wilson MC, Grant CA, Mokete B, Bishop F. Movement of the inner retina complex during the development of primary full-thickness macular holes: implications for hypotheses of pathogenesis. Graefes Arch Clin Exp Ophthalmol. 2015 Dec;253(12):2103-9. doi: 10.1007/s00417-015-2951-0. Epub 2015 Feb 13.

  PMID: 25673252 BACKGROUND

• Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.

  PMID: 24736052 BACKGROUND

• Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616.

  PMID: 25317632 BACKGROUND

• Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11.

  PMID: 27296485 BACKGROUND

• Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.

  PMID: 26469536 BACKGROUND

• Kim YJ, Jo J, Lee JY, Yoon YH, Kim JG. Macular capillary plexuses after macular hole surgery: an optical coherence tomography angiography study. Br J Ophthalmol. 2018 Jul;102(7):966-970. doi: 10.1136/bjophthalmol-2017-311132. Epub 2017 Oct 5.

  PMID: 28982954 BACKGROUND

MeSH Terms

Conditions

Retinal Perforations

Interventions

Predictive Value of Tests

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Islam Mohalhal, MD

  Research Institute of Ophthalmology, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohamed Husssein

CONTACT

+201015479856; mhmm1004@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: December 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 15, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: data will become available before the end of 2024 and will be available for 1 year
• Access Criteria: it will be shared via E-mail

Locations

EG (1)