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Comparative Analysis of Large Macular Hole Surgeries

NCT ID: NCT04116892

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Macular Holes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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the peeling group

the internal limiting membrane was discarded

Group Type ACTIVE_COMPARATOR

the peeling group

Intervention Type PROCEDURE

the internal limiting membrane was discarded

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.

Group Type EXPERIMENTAL

the Cover group

Intervention Type PROCEDURE

The internal limiting membrane around the MH was left to cover the hole

the Fill group

the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.

Group Type EXPERIMENTAL

the Fill group

Intervention Type PROCEDURE

The internal limiting membrane around the MH was left to fill the hole

Interventions

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the Cover group

The internal limiting membrane around the MH was left to cover the hole

Intervention Type PROCEDURE

the Fill group

The internal limiting membrane around the MH was left to fill the hole

Intervention Type PROCEDURE

the peeling group

the internal limiting membrane was discarded

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Jiang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiyong Zhang, docter

Role: CONTACT

[email protected]
13968059392

Facility Contacts

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Zhiyong Zhang, docter

Role: primary

[email protected]
13968059392

Other Identifiers

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2019-142

Identifier Type: OTHER

Identifier Source: secondary_id

IR001094

Identifier Type: -

Identifier Source: org_study_id