Epiretinal MembraneNCT04459949
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
A study testing Sharkskin and Grieshaber in people with Epiretinal Membrane and Macular Holes, run by Wills Eye.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiretinal Membrane, Macular Holes
- What is being tested?
- Sharkskin and Grieshaber
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Macular pathology
Who cannot join
- No prior vitreoretinal surgery
About this study
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.
- Conditions
- Epiretinal Membrane, Macular Holes
- Being tested
- Sharkskin, Grieshaber
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SharkskinDevice
Use of Sharkskin ILM forceps
GrieshaberDevice
Use of Grieshaber ILM forceps
| Study group | Role | What they receive |
|---|---|---|
| Sharkskin Arm | Active comparator | Not described Receives: Device: Sharkskin |
| Grieshaber Arm | Placebo comparator | Not described Receives: Device: Grieshaber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Measured: During surgery
Secondary outcomes (2)
Ease of peeling - surgeon
Use of standardized questionnaire to the surgeon.
Measured: During surgery
Ease of peeling - masked grader
Use of standardized questionnaire to the masked grader.
Measured: Through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start6 Jul 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MidAtlantic Retina, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459949
- Sponsor's protocol ID
- IRB #2020-91
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39047125
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling
- ClinicalTrials.gov ID
- NCT04459949
- Acronym / sponsor ID
- IRB #2020-91
- Conditions
- Epiretinal Membrane, Macular Holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- 6 Jul 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sharkskin Arm | Active comparator | Device: Sharkskin |
| Grieshaber Arm | Placebo comparator | Device: Grieshaber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Macular pathology
Key exclusion criteria (1 listed)
- No prior vitreoretinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SharkskinUse of Sharkskin ILM forceps | Device | Sharkskin Arm |
| GrieshaberUse of Grieshaber ILM forceps | Device | Grieshaber Arm |
Primary outcome
Surgical time
Time frame: During surgery
2 secondary outcomes
Ease of peeling - surgeon
Time frame: During surgery
Ease of peeling - masked grader
Time frame: Through study completion, up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 39047125Starr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sharkskin and Grieshaber in people with Epiretinal Membrane and Macular Holes, run by Wills Eye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.