Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GCP-Service International Ltd. & Co. KG | INDUSTRY |
Not provided
Not provided
Not provided
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:
Participants will:
There is no comparison group in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESBYOND | Participants in this group will receive a personalized laser eye surgery for the correction of presbyopia (Presbyond). The treatment is planned individually for each patient and performed on both eyes. It involves creating a corneal flap with a femtosecond laser, followed by reshaping the cornea with an excimer laser to improve vision at different distances. One eye is mainly corrected for distance and the other for near vision, allowing the brain to combine both images and support everyday visual tasks without glasses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Laser Specialists | Melbourne | VIC/Australia | 3143 | Australia |
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Crystal Eye and laser Center | Craigie | Western Australia | 6025 | Australia |
|
| The Wellington Eye Centre | Wellington | New Zealand | 6011 | New Zealand |
|