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Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

W

Wills Eye

Status

Unknown

Conditions

Macular Holes
Epiretinal Membrane

Treatments

Device: Grieshaber
Device: Sharkskin

Study type

Interventional

Funder types

Other

Identifiers

NCT04459949
IRB #2020-91

Details and patient eligibility

About

The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery.

Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Macular pathology

Exclusion criteria

  • No prior vitreoretinal surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Sharkskin Arm
Active Comparator group
Treatment:
Device: Sharkskin
Grieshaber Arm
Placebo Comparator group
Treatment:
Device: Grieshaber

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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