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Tests treatment safety and results for Cataract
Official title Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
ClinicalTrials.gov ID: NCT06446817
What this study is testing
- What it's testing
- The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation
- No ocular comorbidity possibly affecting the study results
- Fit within the available IOL diopter range
- Have had no previous refractive surgery
- Regular corneal astigmatism ≤1.0 dioptres
You likely can't join if
- Ocular surface disease potentially affecting study results
- Pre-existing ocular pathology or history of pathology potentially affecting the study results
- Acute or chronic disease or illness that would increase risk or confound study results
- people who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
- Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
- Instability of keratometry or biometry measurements
See the full eligibility criteria
- Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation
- No ocular comorbidity possibly affecting the study results
- Fit within the available IOL diopter range
- Have had no previous refractive surgery
- Regular corneal astigmatism ≤1.0 dioptres
- Clear intraocular media other than cataract
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Ability to attend all study follow-ups
- Signed informed consent.
- Ocular surface disease potentially affecting study results
- Pre-existing ocular pathology or history of pathology potentially affecting the study results
- Acute or chronic disease or illness that would increase risk or confound study results
- people who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
- Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
- Instability of keratometry or biometry measurements
- Traumatic cataract
- Amblyopia
- History of ocular trauma or any prior ocular surgery including refractive procedures
- Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
- Pupil abnormalities
- Systemic or ocular medication that could modify pupil dynamics
- Expected complicated surgery or complicated surgery
- Concurrent participation in another drug or device investigation
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
- Montauban, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France; Montauban, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.