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Foveal Sparing of the ILM

U

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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