Clareon TruPlus Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAlcon Research
About this trial
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.
Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
Astigmatism suitable for correction with available toric IOL models.
Other protocol-specified inclusion criteria may apply.
Disqualifiers
Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.
Moderate to severe dry eye that would affect study measurements.
Other protocol-specified exclusion criteria may apply.
Trial design
Design model
Single group
Treatments tested in this trial
Clareon TruPlus Monofocal Non-Toric IOL
DeviceMonofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
Clareon TruPlus Monofocal Toric IOL
DeviceMonofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
Phacoemulsification
Procedure/SurgeryMinimally invasive surgery technique that utilizes ultrasonic vibrations to break up (emulsify) and remove a cloudy lens through a small, self-sealing, 2-3mm incision
Treatment groups
122 Participants
are divided into 1 treatment groupGroup A: Clareon TruPlus Monofocal IOLExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint
Time frame
Day 0 preoperative, Month 1, Month 3, Month 12Sponsors and contacts
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Source ClinicalTrials.gov