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Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser

NCT06960785 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-05-07

No results posted yet for this study

Summary

The goal of this clinical trial is to collect information on vision outcomes in people aged 45 to 65 who have difficulty seeing clearly at near distances due to aging (a condition called presbyopia). All participants will receive the same treatment: laser eye surgery with the PRESBYOND method using the MEL 90 excimer laser.

The main questions this study aims to answer are:

* How well do patients see at distance, intermediate, and near after treatment?
* How satisfied are patients with their vision after surgery?

Participants will:

* Attend seven visits over six months (before surgery and after surgery at 1 day, 1 week, 1 month, 3 months, and 6 months)
* Undergo laser eye surgery with PRESBYOND
* Complete vision tests and questionnaires about their experience

There is no comparison group in this study.

Conditions

Interventions

DEVICE

MEL90 excimer laser - PRESBYOND

Participants will undergo laser eye surgery in both eyes using the PRESBYOND method. First, a thin flap is created on the surface of the eye using a femtosecond laser. Then, a second laser (excimer laser) reshapes the cornea to improve vision at near, intermediate, and far distances. The treatment is similar to monovision techniques, where one eye is mainly corrected for distance and the other for near vision. However, PRESBYOND differs by adjusting the depth of focus in each eye individually, allowing the brain to better combine the two images in the intermediate range-this area is called the "Blend Zone." This approach helps preserve natural binocular (3D) vision, contrast sensitivity, and depth perception. Most patients adapt well and quickly to this type of correction. The procedure is customized based on each patient's age and eye characteristics.

Sponsors & Collaborators

  • GCP-Service International Ltd. & Co. KG

    collaborator INDUSTRY

  • Carl Zeiss Meditec AG

    lead INDUSTRY

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-01-31
Completion
2026-02-28

Countries

  • Australia
  • New Zealand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960785 on ClinicalTrials.gov