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Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04459949
Enrollment
100
Registered
2020-07-07
Start date
2020-07-06
Completion date
2021-06-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Holes

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.

Interventions

DEVICESharkskin

Use of Sharkskin ILM forceps

DEVICEGrieshaber

Use of Grieshaber ILM forceps

Sponsors

Wills Eye
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Macular pathology

Exclusion criteria

* No prior vitreoretinal surgery

Design outcomes

Primary

MeasureTime frame
Surgical timeDuring surgery

Secondary

MeasureTime frameDescription
Ease of peeling - surgeonDuring surgeryUse of standardized questionnaire to the surgeon.
Ease of peeling - masked graderThrough study completion, up to one yearUse of standardized questionnaire to the masked grader.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026