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

This trial does not accept healthy volunteers

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 population

Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

MEL90 excimer laser - PRESBYOND
Device
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.

Treatment groups

75 Participants

are divided into 1 treatment group

Group A: PRESBYOND1 intervention

Trial outcomes

Primary outcomes

Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better

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.

Time frame

6 months after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carl Zeiss Meditec AG

Lead sponsor

GCP-Service International Ltd. & Co. KG

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: