Comparative Analysis of Large Macular Hole Surgeries (CAOLMHS)

Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries

This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.

Study Overview

• Status: Unknown
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: the peeling group; Procedure: the Cover group; Procedure: the Fill group

Detailed Description

Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiyong Zhang, docter; Phone Number: 13968059392; Email: zhangziyongnet@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Zhiyong Zhang, docter; Phone Number: 13968059392; Email: zhangziyongnet@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.

Exclusion Criteria:

• High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the peeling group; the internal limiting membrane was discarded	Procedure: the peeling group; the internal limiting membrane was discarded
Experimental: the Cover group; the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.	Procedure: the Cover group; The internal limiting membrane around the MH was left to cover the hole
Experimental: the Fill group; the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.	Procedure: the Fill group; The internal limiting membrane around the MH was left to fill the hole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MH status	MH status (open, flat open or closed)	at 3 months after surgery
IS/OS line interruption width	IS/OS line interruption width were gauged with spectral-domain optical coherence tomography	at 3 months after surgery
Change from Baseline IS/OS line interruption width at 3 months	IS/OS line interruption width were gauged with spectral-domain optical coherence tomography	at 3 months after surgery
Baseline best-corrected visual acuity	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis	at 3 months after surgery
Change from Baseline best-corrected visual acuity at 3 months	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis	at 3 months after surgery
visual function	visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)	at 3 months after surgery
Change from Baseline visual function at 3 months	visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)	at 3 months after surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Tao Jiang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Macular hole surgery; Inverted Internal Limiting Membrane Flap Technique; Large Macular Hole
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: IR001094; 2019-142 (Other Identifier: 2nd Affiliated Hospital, School of Medicine, Zhejiang University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No