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

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233500
• Other study ID #: FayoumU_28
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: January 2024
• Source: Fayoum University
• Contact: Mohamed Husssein
• Phone: +201015479856
• Email: mhmm1004[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• pars plana vitrectomy
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

Locations

Country	Name	City	State
Egypt	research institute of ophthalmology, Egypt	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Fayoum University	Research Institute of Ophthalmology, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	central retinal thickness	Standard Optical coherence tomography of the macula using (SD-OCT) scans (512 A-scans, 20°×20°) to measure central retinal thickness in µm	It will be measured preoperative and at 1 and 6 months post-operative