Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

NCT ID: NCT04459949

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Epiretinal Membrane Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sharkskin Arm

Group Type ACTIVE_COMPARATOR

Sharkskin

Intervention Type DEVICE

Use of Sharkskin ILM forceps

Grieshaber Arm

Group Type PLACEBO_COMPARATOR

Grieshaber

Intervention Type DEVICE

Use of Grieshaber ILM forceps

Interventions

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Sharkskin

Use of Sharkskin ILM forceps

Intervention Type DEVICE

Grieshaber

Use of Grieshaber ILM forceps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Macular pathology

Exclusion Criteria

* No prior vitreoretinal surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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MidAtlantic Retina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Starr MR, Hinkle JC, Patel LG, Ammar MJ, Soares RR, Patel SN, Cohen MN, Hsu J, Yonekawa Y, Ho AC, Regillo CD, Gupta OP. RANDOMIZED TRIAL COMPARING MICROSERRATED VERSUS CONVENTIONAL INTERNAL LIMITING MEMBRANE FORCEPS FOR INTERNAL LIMITING MEMBRANE PEELING. Retina. 2024 Aug 1;44(8):1323-1328. doi: 10.1097/IAE.0000000000004138.

Reference Type DERIVED
PMID: 39047125 (View on PubMed)

Other Identifiers

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IRB #2020-91

Identifier Type: -

Identifier Source: org_study_id

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