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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 May 2016 |
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Main ID: |
NCT02605408 |
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Date of registration:
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06/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cataract Surgery in Indian Patients With or Without LenSx® Laser
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Scientific title:
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A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02605408 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Head Medical Affairs, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alcon India Pvt. Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
- Understand and sign an informed consent form;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Refuse to sign the informed consent form or have incomplete medical records;
- Contraindications for phacoemulsification treatment per Investigator discretion or
listed in LenSx® Operator's Manual;
- Contraindications for anterior capsulotomy, phacofragmentation of the lens using the
FLACS;
- Other protocol-specified exclusion criteria may apply.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cataracts
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Intervention(s)
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Device: LenSx® laser system
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Procedure: Phacoemulsification
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Primary Outcome(s)
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Cumulative dissipated energy (CDE)
[Time Frame: Day 0, operative day]
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Uncorrected Visual Acuity (UCVA)
[Time Frame: Up to Day 30 postoperative]
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Completion rate of an anterior capsulotomy
[Time Frame: Day 0, operative day]
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Success rate of IOL insertion
[Time Frame: Day 0, operative day]
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Aspiration fluid (ml)
[Time Frame: Day 0, operative day]
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Total phaco + IOL time
[Time Frame: Day 0, operative day]
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Completion rate of cornea incision
[Time Frame: Day 0, operative day]
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Best Corrected Visual Acuity (BCVA)
[Time Frame: Up to Day 30 postoperative]
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Laser procedure time from suction on to off
[Time Frame: Day 0, operative day]
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Secondary ID(s)
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CTI742-P001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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