Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Sponsor
Wills Eye (Other)
Overall Status
Unknown status
CT.gov ID
NCT04459949
Collaborator
(none)
100
2
10.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sharkskin
  • Device: Grieshaber
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
Anticipated Study Start Date :
Jul 6, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Surgical time [During surgery]

Secondary Outcome Measures

  1. Ease of peeling - surgeon [During surgery]

    Use of standardized questionnaire to the surgeon.

  2. Ease of peeling - masked grader [Through study completion, up to one year]

    Use of standardized questionnaire to the masked grader.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Macular pathology
Exclusion Criteria:
  • No prior vitreoretinal surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wills Eye

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MidAtlantic Retina, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier:
NCT04459949
Other Study ID Numbers:
  • IRB #2020-91
First Posted:
Jul 7, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2020