NCT05083650

Brief Summary

Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter \> 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

June 25, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

June 25, 2019

Last Update Submit

October 18, 2021

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (1)

  • % of macular hole clousure measured with OCT

    Closure of the macular hole by optical coherence tomography

    6 months

Secondary Outcomes (2)

  • Best-corrected visual acuity measured with Snellen Chart

    6 months

  • Superficial and deep retinal capillary plexus density with OCT-A

    6 months

Study Arms (2)

Amniotic membrane without internal limiting membrane peeling

EXPERIMENTAL

The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade.

Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

Amniotic membrane with internal limiting membrane peeling

ACTIVE COMPARATOR

The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade.

Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

Interventions

Macular hole closure with amniotic membrane with/without internal limiting membrane peelingPROCEDURE

Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade

Amniotic membrane with internal limiting membrane peelingAmniotic membrane without internal limiting membrane peeling

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not myopic patients (\<6 Dioptre or \<26 mm)
  • Large macular hole \>550 μm
  • \> 6 months symptoms
  • Signing informed consent

You may not qualify if:

  • Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
  • Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
  • Patients with ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Oftalmologia Conde de Valenciana

Mexico City, 06800, Mexico

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Daniel Rios Esquer, MD

    Instituto de Oftalmologia Conde de Valenciana

    PRINCIPAL INVESTIGATOR

  • Ishtar A Astorga Carballo, MD

    Instituto de Oftalmologia Conde de Valenciana

    PRINCIPAL INVESTIGATOR

  • Jose L Rodriguez Loaiza, MD

    Instituto de Oftalmologia Conde de Valenciana

    PRINCIPAL INVESTIGATOR

  • Zita Chao Loyo, MD

    Instituto de Oftalmologia Conde de Valenciana

    PRINCIPAL INVESTIGATOR

  • Felipe Esparza Correa, MD

    Instituto de Oftalmologia Conde de Valenciana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zita Chao Loyo, MD

CONTACT

+52 33994182investigacionretinaconval@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
We never let the patient know the performed surgery
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Large MHs (diameter \> 550 μm)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Subdirector

Study Record Dates

First Submitted

June 25, 2019

First Posted

October 19, 2021

Study Start

March 10, 2021

Primary Completion

December 10, 2022

Study Completion

March 10, 2023

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

ME(1)