NCT03174639

Brief Summary

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

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

March 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 23, 2017

Last Update Submit

May 31, 2017

Conditions

High MyopiaMacular HolesRetinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Closure of macular hole

    Closure of macular hole demonstrated by optical coherence tomography

    3 months

Secondary Outcomes (1)

  • Retinal reattachment

    3 months

Study Arms (1)

Inverted and free ILM insertion

EXPERIMENTAL

Both inverted and free ILM flaps were inserted into the macular hole

Procedure: Inverted and free ILM insertion

Interventions

Inverted and free ILM insertionPROCEDURE

ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.

Inverted and free ILM insertion

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Macular hole with retinal detachment in high myopia

You may not qualify if:

  • History of trauma, peripheral retinal breaks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.

    PMID: 28845304DERIVED

MeSH Terms

Conditions

Retinal PerforationsRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 2, 2017

Study Start

March 11, 2016

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share