Foveal Sparing of the ILM

Università degli Studi di Brescia

Status: Completed

Conditions: Retinal Sensitivity

Treatments: Procedure: Complete Macular Peeling; Procedure: Macular Peeling with Foveal Sparing

Study type: Interventional

Funder types: Other

Identifiers

NCT03488576

Vitreo003

Details and patient eligibility

About

To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.

Enrollment: 190 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provision of written informed consent
• age > 60 years
• presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion criteria

• any prior intraocular surgery
• pathologic myopia (> 7 diopters)
• age related macular degeneration
• glaucoma and diabetic retinopathy or any other retinal vascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Complete Peeling

Active Comparator group

Description:

Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.

Treatment:

Procedure: Complete Macular Peeling

Foveal Sparing

Experimental group

Description:

Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).

Treatment:

Procedure: Macular Peeling with Foveal Sparing