Clinical trial NCT06960785: Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
Official title: Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Presbyopia
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
Collaborators: name: GCP-Service International Ltd. & Co. KG
First posted: 2025-05-07
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.

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.


Eligibility criteria: 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 outcomes:
measure: Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Eye Laser Specialists
state: VIC/Australia
city: Craigie
country: Australia
facility: Crystal Eye and laser Center
state: Western Australia
city: Wellington
country: New Zealand
facility: The Wellington Eye Centre
Study officials:
References: