Back to resultsComparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Primary Purpose
Epiretinal Membrane, Macular Holes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sharkskin
Grieshaber
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- Macular pathology
Exclusion Criteria:
- No prior vitreoretinal surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sharkskin Arm
Grieshaber Arm
Arm Description
Outcomes
Primary Outcome Measures
Surgical time
Secondary Outcome Measures
Ease of peeling - surgeon
Use of standardized questionnaire to the surgeon.
Ease of peeling - masked grader
Use of standardized questionnaire to the masked grader.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04459949
Brief Title
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Official Title
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2020 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Holes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sharkskin Arm
Arm Type
Active Comparator
Arm Title
Grieshaber Arm
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Sharkskin
Intervention Description
Use of Sharkskin ILM forceps
Intervention Type
Device
Intervention Name(s)
Grieshaber
Intervention Description
Use of Grieshaber ILM forceps
Primary Outcome Measure Information:
Title
Surgical time
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Ease of peeling - surgeon
Description
Use of standardized questionnaire to the surgeon.
Time Frame
During surgery
Title
Ease of peeling - masked grader
Description
Use of standardized questionnaire to the masked grader.
Time Frame
Through study completion, up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Macular pathology
Exclusion Criteria:
No prior vitreoretinal surgery
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
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