Status:
COMPLETED
Next Generation Cataract Surgery Study
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.
Detailed Description
Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (s...
Eligibility Criteria
Inclusion
- Key
- Able to understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled visits as required by the protocol.
- Clinically documented diagnosis of age-related noncomplicated cataract.
- Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
- Other protocol-defined inclusion criteria may apply.
- Key
Exclusion
- Women of childbearing potential as defined in the protocol.
- Planned postoperative procedures during the course of the study in the operative eye.
- Previous intraocular or corneal surgery in the operative eye.
- Diagnosis of glaucoma or ocular hypertension (IOP \> 21 mmHg) in the operative eye.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT06071104
Start Date
December 6 2023
End Date
June 28 2024
Last Update
June 4 2025
Active Locations (4)
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1
Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center
San Diego, California, United States, 92122
2
Miramar Eye Specialists Medical Group
Ventura, California, United States, 93003
3
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
4
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108