Comparative Analysis of Large Macular Hole Surgeries

Not Applicable

• Conditions: Macular Holes
• Interventions: Procedure: the Cover group; Procedure: the peeling group; Procedure: the Fill group

• Registration Number: NCT04116892
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-27
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
the Cover group	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.
the peeling group	the peeling group	the internal limiting membrane was discarded
the Fill group	the Fill group	the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.

Primary Outcome Measures

Name	Time	Method
MH status	at 3 months after surgery	MH status (open, flat open or closed)
IS/OS line interruption width	at 3 months after surgery	IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Change from Baseline IS/OS line interruption width at 3 months	at 3 months after surgery	IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Baseline best-corrected visual acuity	at 3 months after surgery	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
Change from Baseline best-corrected visual acuity at 3 months	at 3 months after surgery	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
visual function	at 3 months after surgery	visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Change from Baseline visual function at 3 months	at 3 months after surgery	visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)

Trial Locations

Locations (1)

Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China