PresbyopiaNCT06960785
Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
An observational study of Presbyopia, run by Carl Zeiss Meditec AG at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- MEL90 excimer laser - PRESBYOND
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.
Who may be able to join
- 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
Show all 9Show fewer
- Availability, willingness, to comply with examination follow up visits
- Signed informed consent and data protection documents
- Patients successfully passed the tolerance test
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Australia2 sites
Crystal Eye and laser Center
Craigie, Western Australia, 6025
Lourens Dr. van Zyl, +614863742381, lourens.vanzyl@crystaleye.com.au
Courtney Beggs, patientcare@crystaleye.com.au
Eye Laser Specialists
Melbourne, VIC/Australia, 3143
Anton Dr. van Heerden, +61390700910, anton@eyelaserspecialists.com.au
Cleopatra Mhlanga, ctm@zave.com.au
New Zealand1 site
The Wellington Eye Centre
Wellington, New Zealand, 6011
Andrew Dr. Logan, +6443858833, andrew@wefixeyes.co.nz
Maisie Hall, maisie@wefixeyes.co.nz
About this study
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:
Read more
- 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.
- Conditions
- Presbyopia
- Being tested
- MEL90 excimer laser - PRESBYOND
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEL90 excimer laser - PRESBYONDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MEL90 excimer laser - PRESBYOND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study startMay 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GCP-Service International Ltd. & Co. KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960785
- Sponsor's protocol ID
- GPAS-REF-024-02
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
- ClinicalTrials.gov ID
- NCT06960785
- Acronym / sponsor ID
- GPAS-REF-024-02
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Collaborators
- GCP-Service International Ltd. & Co. KG
- Study start
- May 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRESBYOND | – | Device: MEL90 excimer laser - PRESBYONDParticipants 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants scheduled to undergo laser eye surgery in both eyes using the PRESBYOND method.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEL90 excimer laser - PRESBYONDParticipants 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. | Device | PRESBYOND |
Primary outcome
Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by Carl Zeiss Meditec AG at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.