NCT04459949

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

June 29, 2020

Last Update Submit

July 2, 2020

Conditions

Epiretinal MembraneMacular Holes

Outcome Measures

Primary Outcomes (1)

  • Surgical time

    During surgery

Secondary Outcomes (2)

  • Ease of peeling - surgeon

    During surgery

  • Ease of peeling - masked grader

    Through study completion, up to one year

Study Arms (2)

Sharkskin Arm

ACTIVE COMPARATOR
Device: Sharkskin

Grieshaber Arm

PLACEBO COMPARATOR
Device: Grieshaber

Interventions

SharkskinDEVICE

Use of Sharkskin ILM forceps

Sharkskin Arm
GrieshaberDEVICE

Use of Grieshaber ILM forceps

Grieshaber Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Macular pathology

You may not qualify if:

  • No prior vitreoretinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39047125DERIVED

MeSH Terms

Conditions

Epiretinal MembraneRetinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 7, 2020

Study Start

July 6, 2020

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share