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Epiretinal MembraneNCT06753539

Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes

A study testing ILM forceps - membrane grasping in people with Epiretinal Membrane, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site". The main questions it aims to answer are: 1. are there differences in grasp attempts between both forceps 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epiretinal Membrane
What is being tested?
ILM forceps - membrane grasping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteAustria
Study dates
12 May 2023to 1 Dec 2024
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic ERM
  • Sheduled surgery (vitrectomy with membrane peeling), as defined by vision loss and/or metamorphopsia
  • Age 18 and older
  • Written informed consent for participation in the study

Who cannot join

  • Macular edema due to other reasons than iERM
  • Pregnancy (pregnancy test will be performed in women of reproductive age)

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Hanusch Hospital, Department of Ophthalmology

    Vienna, 1140

Other trials in Austria

About this study

Official title: Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes With Different ILM Forceps - a Prospective Randomized Study

The goal of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site". The main questions it aims to answer are:

  1. are there differences in grasp attempts between both forceps
  2. are there differences in Instrument tissue interactions between both forceps
  3. are there differences in postsurgical anatomical and functional outcomes at the grasp site between both forceps.
Read the detailed description

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. The surgical method has been used for some time, the first report on the surgical method of vitrectomy with membrane peeling dates back to 1978, and since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Our group has been able to record "stretching" of the retinal tissue using this technique and has also been able to record the rarely occurring subfoveal and extrafoveal elevations of the ellipsoidal zone due to membrane peeling. These changes did not significantly affect postoperative visual acuity in our study population but did affect the development of postoperative microscotomas. Besides "retinal stretching" during surgery, ILM peeling is shown to be another factor with association of new postoperative microscotomas. New postoperative microscotomas developed in some patients without "retinal stretching" and ILM peeling. Apart from these already known iatrogenic changes, the analysis of the "grasp site" at the "starting point" of epiretinal membrane peeling is of great interest, because at this location, grasping of the epiretinal membrane may be difficult especially in case of an adherent ERM and superficial retinal lesions may be induced.

Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.

The aim of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site".

Being tested
ILM forceps - membrane grasping
Medical subject headings
Epiretinal Membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILM forceps - membrane graspingDevice

    grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps.

Study groups in NCT06753539
Study groupRoleWhat they receive
ILM sharkskin forcepsExperimentalPatients were operated on using an ILM forceps with a laser-modified microstructure on the branches.
Receives: Device: ILM forceps - membrane grasping
conventional ILM forcepsActive comparatorPatients were operated on using a conventional ILM forceps with plain surfaces on the branches.
Receives: Device: ILM forceps - membrane grasping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. grasp attempts

    number of attemps needed for opening the epiretinal membrane during grasping

    Measured: during surgery

Secondary outcomes (6)

  1. metamorphopsia

    Presence of metamorphopsia is tested with the Amsler grid and M-charts

    Measured: before and 3 months after surgery

  2. microscotomata

    New deep microscotomata is tested with microperimetry

    Measured: before and 3 months after surgery

  3. Thinning of the ganglion cell layer

    Thinning of the ganglion cell layer is assessed with optical coherence tomography

    Measured: before and 3 months after surgery

  4. Central subfield thickness

    Central subfield thickness of the macula is assessed with optical coherence tomography

    Measured: before and 3 months after surgery

  5. Best corrected distant visual acuity

    Best corrected distant visual acuity is assessed by EDTRS-charts

    Measured: before and 3 months after surgery

  6. OCT biomarkers

    OCT biomarkers are assessed by optical coherence tomography

    Measured: before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start12 May 2023
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Resources

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
Model description
Patients were operated on using either an ILM forceps with a laser-modified microstructure on the branches (group A) or a conventional ILM forceps (group B). Patients are randomized to both groups.
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753539
Sponsor's protocol ID
SIF
Status last verified
Feb 2025
First submitted
21 Dec 2024
Last updated
13 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. doi: 10.1016/s0161-6420(97)30190-0.

    PubMed 9186446

  • Machemer R. [The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Klin Monbl Augenheilkd. 1978 Jul;173(1):36-42. German.

    PubMed 692034

  • Leisser C, Palkovits S, Hienert J, Ullrich M, Zwickl H, Georgiev S, Findl O. Effect of Iatrogenic Traction during Macular Peeling Surgery on Postoperative Microperimetry. Ophthalmic Res. 2021;64(2):273-279. doi: 10.1159/000507633. Epub 2020 Apr 1.

    PubMed 32235121

  • Leisser C, Hackl C, Hirnschall N, Findl O. Effect of Subfoveal and Extrafoveal Hyporeflective Zones due to Iatrogenic Traction during Membrane Peeling for Epiretinal Membranes on Postoperative Outcomes. Ophthalmologica. 2020;243(4):297-302. doi: 10.1159/000505214. Epub 2019 Dec 5.

    PubMed 31801147

  • Diaz RI, Randolph JC, Sigler EJ, Calzada JI. Intraoperative grasp site correlation with morphologic changes in retinal nerve fiber layer after internal limiting membrane peeling. Ophthalmic Surg Lasers Imaging Retina. 2014 Jan-Feb;45(1):45-9. doi: 10.3928/23258160-20131220-06.

    PubMed 24392911

Questions about this trial

What is this clinical trial studying?

A study testing ILM forceps - membrane grasping in people with Epiretinal Membrane, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

grasp attempts (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 NCT06753539, which also lists 5 linked publications.

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 13 Feb 2025.

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