Recruiting soon

Refractive Outcomes of PRESBYOND Laser Surgery for Presbyopia

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Eye Diseases

+ Presbyopia

+ Refractive Errors

From 45 to 65 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2025
See protocol details

Summary

Principal SponsorCarl Zeiss Meditec AG
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on understanding the effectiveness of a specific type of laser eye surgery, known as the PRESBYOND method, for improving vision in people aged 45 to 65 who have presbyopia. Presbyopia is a common age-related condition where people struggle to see things up close. The study aims to gather detailed information on how well patients can see at various distances—far, intermediate, and near—after undergoing this laser treatment. Additionally, it seeks to assess how satisfied patients are with their vision following the surgery. By doing so, the study hopes to provide insights that could enhance treatment options for those affected by presbyopia. Participants in this study will undergo laser eye surgery using the MEL 90 excimer laser, which is a specific type of laser used in the PRESBYOND method. They will attend seven visits over a six-month period, starting from before the surgery and continuing with regular check-ups after the procedure at intervals of 1 day, 1 week, 1 month, 3 months, and 6 months. During these visits, participants' vision will be tested using standard vision charts to measure how well they see without glasses at close range, with the main focus being on the clarity of their near vision after six months. Participants will also fill out questionnaires to share their experiences and satisfaction with the surgery. There are no groups for comparison in this study, meaning all participants receive the same treatment.

Official TitleEvaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
NCT06960785
Principal SponsorCarl Zeiss Meditec AG
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesPresbyopiaRefractive Errors

Criteria

9 inclusion criteria required to participate
Subjects between 45 and 65 years old

Scheduled to undergo bilateral LASIK treatment with PRESBYOND

Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye

Normal corneal topography in each eye

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11 exclusion criteria prevent from participating
Mixed astigmatism in any eye

Irregular corneal astigmatism in any eye

Clinically significant ocular surface disease in any eye

History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Eye Laser Specialists

Melbourne, AustraliaOpen Eye Laser Specialists in Google Maps
Suspended

Crystal Eye and laser Center

Craigie, Australia
Suspended

The Wellington Eye Centre

Wellington, New Zealand
Recruiting soon3 Study Centers