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Not yet recruiting NCT06960785

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

— Observational Presbyopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MEL90 excimer laser - PRESBYOND.
Who it may be relevant to
Registry conditions: Presbyopia. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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,

Primary outcome measures

  • Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better [Time frame: 6 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 2 centers
  • Eye Laser Specialists — Melbourne
  • Crystal Eye and laser Center — Craigie
New Zealand · 1 center
  • The Wellington Eye Centre — Wellington

Identifiers

NCT: NCT06960785 · GPAS-REF-024-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗