NCT03528122

Brief Summary

Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

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

February 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

April 21, 2018

Last Update Submit

February 18, 2020

Conditions

Macula HoleRetinal DetachmentMyopic Macular Degeneration

Keywords

amniotic membraneretinal detachmentMyopicmacular holeinternal limiting membrane

Outcome Measures

Primary Outcomes (1)

  • Anatomical restoration of macular hole closure

    Closure of the macular hole

    6 months

Secondary Outcomes (2)

  • Functional restoration after closure of the macular hole

    6 months

  • Functional restoration after closure of the macular hole

    6 months

Study Arms (1)

Recurrent opened macular hole

EXPERIMENTAL

Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft

Procedure: Recurrent opened macular hole

Interventions

Recurrent opened macular holePROCEDURE

pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade

Recurrent opened macular hole

Eligibility Criteria

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

You may qualify if:

  • Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
  • Opened holes after 1 month of the surgery.
  • Myopic macular holes only were included (Refraction of more than \_6 D and/or axial length of more than 26 mm).

You may not qualify if:

  • All other causes of macular hole (traumatic and idiopathic)
  • Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia UNiversity hospital

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Retinal PerforationsRetinal DetachmentMyopia

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesRefractive Errors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Individuals with recurrent macular hole associated retinal detachment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 17, 2018

Study Start

February 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

EG(1)