Zeiss RESIGHT Disposable Lenses Evaluation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the intra-operative efficacy of a new intra-operative viewing device.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

NCT05427526

Vitreous Disorder Cataract

COMPLETED NA

Visual Outcomes After Presbyopic Lens Exchange

NCT03790592

Presbyopia

COMPLETED NA

Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures

NCT03856346

Intraocular Lens Calculation Combined Phaco-vitrectomy

UNKNOWN

Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens

NCT04998409

Cataract Senile

COMPLETED

Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX

NCT00842959

Cataract

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.

Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment Macular Pucker Macular Holes Vitreomacular Traction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

primary vitrectomy surgery for retinal detachment

Group Type ACTIVE_COMPARATOR

ZEISS disposable

Intervention Type DEVICE

a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.

group 2

macular surgery: pucker, vitreomacular traction or macular hole

Group Type ACTIVE_COMPARATOR

ZEISS disposable

Intervention Type DEVICE

a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ZEISS disposable

a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
* Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction).
* Both vitrectomy-only and combined phaco-vitrectomy surgeries
* General or local anesthesia, or combination

Exclusion Criteria

* Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
* Repeat vitrectomy surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes