Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
ConditionPresbyopia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-65
SponsorCarl Zeiss Meditec AG
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MEL90 excimer laser - PRESBYOND
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Carl Zeiss Meditec AG
Lead sponsor
GCP-Service International Ltd. & Co. KG
Collaborator
Source ClinicalTrials.gov