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To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.

NCT05396209 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-31

No results posted yet for this study

Summary

To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH).

Conditions

  • Macular Holes

Interventions

PROCEDURE

Hydrated Amniotic Membrane Plug

Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole

PROCEDURE

ILM filling

The ILM filling technique - Rossi et al show that ILM filling technique was more efficacious in closing full-thickness macular holes larger than 630μm, in which the free ILM after peeling is plug into the area of the macular hole

PROCEDURE

Conventional ILM peeling

Peeling with complete removal of the internal limiting membrane within the vascular arch

Sponsors & Collaborators

  • Oriental Neurosurgery Evidence-Based-Study Team

    lead OTHER

Principal Investigators

  • Hua Yan, MD,PhD · Ophthalmology of Tianjin Medical University General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-05-15
Completion
2025-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396209 on ClinicalTrials.gov