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Completed

NCT Number: NCT06753539

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

ILM forceps - membrane grasping

Device

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

Primary outcomes

  1. grasp attempts

    Time frame: during surgery

    number of attemps needed for opening the epiretinal membrane during grasping

Secondary outcomes

  1. metamorphopsia

    Time frame: before and 3 months after surgery

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

  2. microscotomata

    Time frame: before and 3 months after surgery

    New deep microscotomata is tested with microperimetry

  3. Thinning of the ganglion cell layer

    Time frame: before and 3 months after surgery

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

  4. Central subfield thickness

    Time frame: before and 3 months after surgery

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

  5. Best corrected distant visual acuity

    Time frame: before and 3 months after surgery

    Best corrected distant visual acuity is assessed by EDTRS-charts

  6. OCT biomarkers

    Time frame: before surgery

    OCT biomarkers are assessed by optical coherence tomography

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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