NCT04116892

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

September 29, 2019

Last Update Submit

October 25, 2020

Conditions

Macular Holes

Keywords

Inverted Internal Limiting Membrane Flap TechniqueLarge Macular HoleMacular hole surgery

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

the peeling group

ACTIVE COMPARATOR

the internal limiting membrane was discarded

Procedure: the peeling group

the Cover group

EXPERIMENTAL

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 Fill group

EXPERIMENTAL

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

Interventions

the Cover groupPROCEDURE

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

the Cover group
the Fill groupPROCEDURE

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

the Fill group
the peeling groupPROCEDURE

the internal limiting membrane was discarded

the peeling group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Tao Jiang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Zhang, docter

CONTACT

13968059392zhangziyongnet@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 7, 2019

Study Start

May 1, 2019

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)