Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Wenzhou Medical University

Status: Unknown

Conditions: Macular Holes

Treatments: Procedure: Large extent of ILM Peeling; Procedure: Small extent of ILM Peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT03805763

ZZD-Macular Hole

Details and patient eligibility

About

Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clear diagnosis of macular hole;
• The minimum diameter of the macular hole is >400 μm;
• Without serious systemic disease that make patients can not be operated;

Exclusion criteria

• suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
• opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
• eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
• traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
• having a history of vitrectomy surgery;
• glaucoma in stage of preclinical, severe stenosis or closure;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Large extent of ILM Peeling

Experimental group

Description:

Extent of ILM peeling is 4DD and the ILM flap is inserted

Treatment:

Procedure: Large extent of ILM Peeling

Small extent of ILM Peeling

Experimental group

Description:

Extent of ILM peeling is 2DD and the ILM flap is inserted

Treatment:

Procedure: Small extent of ILM Peeling