Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

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.

Study Overview

• Status: Unknown
• Conditions: Epiretinal Membrane; Macular Holes
• Intervention / Treatment: Device: Sharkskin; Device: Grieshaber

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Macular pathology

Exclusion Criteria:

• No prior vitreoretinal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sharkskin Arm	Device: Sharkskin; Use of Sharkskin ILM forceps
Placebo Comparator: Grieshaber Arm	Device: Grieshaber; Use of Grieshaber ILM forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical time	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of peeling - surgeon	Use of standardized questionnaire to the surgeon.	During surgery
Ease of peeling - masked grader	Use of standardized questionnaire to the masked grader.	Through study completion, up to one year

Collaborators and Investigators

• Sponsor: Wills Eye

Study record dates

Study Major Dates

• Study Start (Anticipated): July 6, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Epiretinal Membrane
• Other Study ID Numbers: IRB #2020-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No