Status:
NOT_YET_RECRUITING
Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
Lead Sponsor:
Carl Zeiss Meditec AG
Collaborating Sponsors:
GCP-Service International Ltd. & Co. KG
Conditions:
Presbyopia
Eligibility:
All Genders
45-65 years
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). ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06960785
Start Date
May 1 2025
End Date
February 1 2026
Last Update
May 7 2025
Active Locations (3)
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1
Eye Laser Specialists
Melbourne, VIC/Australia, Australia, 3143
2
Crystal Eye and laser Center
Craigie, Western Australia, Australia, 6025
3
The Wellington Eye Centre
Wellington, New Zealand, New Zealand, 6011