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Management Decision
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The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.
Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract surgery | Phacoemulsification and artificial IOL implantation with and without LenSx® laser system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LenSx® laser system | Device | Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of an anterior capsulotomy | Day 0, operative day | |
| Best Corrected Visual Acuity (BCVA) | Up to Day 30 postoperative | |
| Uncorrected Visual Acuity (UCVA) | Up to Day 30 postoperative | |
| Cumulative dissipated energy (CDE) | Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds. | Day 0, operative day |
| Total phaco + IOL time | Day 0, operative day | |
| Aspiration fluid (ml) | Day 0, operative day | |
| Success rate of IOL insertion | Day 0, operative day | |
| Completion rate of cornea incision | Day 0, operative day | |
| Laser procedure time from suction on to off | Day 0, operative day |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period
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| Name | Affiliation | Role |
|---|---|---|
| Head Medical Affairs, MD | Alcon India Pvt. Ltd. | Study Director |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Phacoemulsification | Procedure | Removal of the cataractous lens |
|
| D059708 | Ultrasonic Surgical Procedures |