Presbyopia
Conditions
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.
Interventions
DEVICEMEL90 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.
Sponsors
GCP-Service International Ltd. & Co. KG
Carl Zeiss Meditec AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better | 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. |
Countries
Australia, New Zealand
Outcome results
None listed