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Clinical Trials in Australia / NCT06960785
Starting soon Observational

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

NCT06960785 · tracked via the Priya Life Science Australia tracker
Phase
Observational
Started
2025-05
Last updated
2025-05-07

Condition(s) studied

Presbyopia

Investigational drug(s) / intervention(s)

MEL90 excimer laser - PRESBYOND

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.

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects between 45 and 65 years old 2. Scheduled to undergo bilateral LASIK treatment with PRESBYOND 3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye 4. Normal corneal topography in each eye 5. Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination 6. Residual stromal thickness ≥250 microns in each eye 7. Availability, willingness, to comply with examination follow up visits 8. Signed informed consent and data protection documents 9. Patients successfully passed the tolerance test Exclusion Criteria: 1. Mixed astigmatism in any eye 2. Irregular corneal astigmatism in any eye 3. Clinically significant ocular surface disease in any eye 4. 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 5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye 6. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye 7. Clinically significant pupil abnormalities in any eye 8. Use of systemic or ocular medications that may affect visual outcomes 9. Systemic pathology that may affect the results of the study 10. Pregnancy or being treated for conditions associated with hormonal fluctuation 11. Participation in another clinical trial in the last 30 days

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Eye Laser Specialists Melbourne VIC/Australia
Crystal Eye and laser Center Craigie Western Australia
The Wellington Eye Centre Wellington New Zealand

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960785 on ClinicalTrials.gov ↗ ← All trials in Australia