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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Laser Specialists, Melbourne, VIC/Australia, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 6 months after surgery

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.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Collaborators

GCP-Service International Ltd. & Co. KG

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 7, 2025
Registry last updated: May 7, 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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