NCT04655781

Brief Summary

The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

November 30, 2020

Last Update Submit

November 30, 2020

Conditions

Internal Limiting Membrane Peeling

Keywords

Retinal displacementIdiopathic macular holeInternal limiting membrane peeling

Outcome Measures

Primary Outcomes (1)

  • T-OD

    measurement of temporal vessel to optic disc

    preoperation to postoperative 6 months

Study Arms (2)

N-T group

EXPERIMENTAL

ILM was peeled off from nasal retina to temporal retina.

Procedure: idiopathic macular hole (MH) surgery

T-N group

EXPERIMENTAL

ILM was peeled off from temporal retina to nasal retina

Procedure: idiopathic macular hole (MH) surgery

Interventions

idiopathic macular hole (MH) surgeryPROCEDURE

Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns

N-T groupT-N group

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eyes with idiopathic macular hole

You may not qualify if:

  • Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

January 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

December 7, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share