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Official title Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg
ClinicalTrials.gov ID: NCT06327347
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 50 \< Age \< 85 years old
- Bilateral age-related cataract
- Signed informed consent of the study
- Availability, willingness and sufficient cognitive awareness to comply with study procedures
- No previous refractive or ocular surgery
You likely can't join if
- Patient consent withdrawal
- Inability to place the intraocular lens safely at the location planned.
- Surgical complications (e.g. non-circular rhexis, oversized or undersized rhexis). Each patient with these intraoperative complications should not be...
See the full eligibility criteria
- 50 \< Age \< 85 years old
- Bilateral age-related cataract
- Signed informed consent of the study
- Availability, willingness and sufficient cognitive awareness to comply with study procedures
- No previous refractive or ocular surgery
- Need for IOL in this diopter range: 10 to 30 D
- Expected postoperative astigmatism ≤ 0.75 D
- Eye dryness ≤ 2 in dry eye severity grading
- For women of childbearing potential: Willing to adhere to an adequate form of contraception. Non-
- Being under guardianship / curatorship
- Illiterate or not enough knowledge of German language
- Acute or chronic disease or illness that would increase risk or confound study results found to be relevant by the investigators
- Pupil \> 4mm or \< 2mm in photopic conditions
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- Occupation requiring night-time driving or any occupation incompatible with multifocality
- Amblyopia, strabismus, color blindness
- Extremely shallow anterior chamber
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome)
- Irregular astigmatism, unstable cornea
- Pregnant or women of childbearing potential or breastfeeding women
- Patient consent withdrawal
- Inability to place the intraocular lens safely at the location planned.
- Surgical complications (e.g. non-circular rhexis, oversized or undersized rhexis). Each patient with these intraoperative complications should not be implanted with the study IOL.
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Germany. 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.