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

NCT06960785 | Not Yet Recruiting

• 1 other identifier: GPAS-REF-024-02
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 3

Brief 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

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better

  The primary endpoint of the study is the proportion of patients achieving a binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better at 6 months postoperatively. Near visual acuity is assessed using standardized near vision charts under controlled lighting conditions, following standard clinical protocols. Measurements are taken binocularly to reflect functional vision in daily life.

  6 months after surgery

Study Arms (1)

PRESBYOND

Participants in this group will receive a personalized laser eye surgery for the correction of presbyopia (Presbyond). The treatment is planned individually for each patient and performed on both eyes. It involves creating a corneal flap with a femtosecond laser, followed by reshaping the cornea with an excimer laser to improve vision at different distances. One eye is mainly corrected for distance and the other for near vision, allowing the brain to combine both images and support everyday visual tasks without glasses.

Device: MEL90 excimer laser - PRESBYOND

Interventions

MEL90 excimer laser - PRESBYOND DEVICE

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.

PRESBYOND

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.

You may qualify if:

• 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
• Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
• Residual stromal thickness ≥250 microns in each eye
• Availability, willingness, to comply with examination follow up visits
• Signed informed consent and data protection documents
• Patients successfully passed the tolerance test

You may not qualify if:

• 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
• Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
• Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
• Clinically significant pupil abnormalities in any eye
• Use of systemic or ocular medications that may affect visual outcomes
• Systemic pathology that may affect the results of the study
• Pregnancy or being treated for conditions associated with hormonal fluctuation
• Participation in another clinical trial in the last 30 days

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead
• GCP-Service International Ltd. & Co. KG: collaborator

Study Sites (3)

Eye Laser Specialists

Melbourne, VIC/Australia, 3143, Australia

Location

Crystal Eye and laser Center

Craigie, Western Australia, 6025, Australia

Location

The Wellington Eye Centre

Wellington, New Zealand, 6011, New Zealand

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

AU (2); NZ (1)