Cataract surgery in Indian patients with or without LenSx laser.
- Conditions
- Health Condition 1: null- Patients undergoing planned cataract surgery
- Registration Number
- CTRI/2015/12/006460
- Lead Sponsor
- Alcon Laboratories India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 2000
1.Males or females, >=21 years old, who will undergo phacoemulsification cataract surgery in at least one eye;
2.Above patients who have the ability to understand and sign an informed consent form.
1.Patients who refuse to sign the informed consent form or donâ??t have complete medical records.
2.Patients who have contraindications for Phacoemulsification treatment per PI discretion or those listed in LenSx Operatorâ??s Manual;
Contraindications for the anterior capsulotomy, phacofragmentation of the lens using the
FLACS include the following:
•Corneal disease that precludes applanation of the cornea or transmission of laser light
at 1030 nm wavelength
•Descemetocele with impending corneal rupture
•Corneal opacity that would interfere with the laser beam
•Presence of blood or other material in the anterior chamber
•Hypotony, glaucoma, or the presence of a corneal implant
•Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy
•Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
•Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
•A history of lens or zonular instability
•Any contraindications to cataract surgery
•Pediatric patients
Contraindications for corneal incisions using the FLACS include the following:
•Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape
•Corneal thickness requirements that are beyond the range of the system
•Corneal opacity that would interfere with the laser beam
•Hypotony or the presence of a corneal implant
•Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
•Pediatric patients
Potential contraindications are not limited to those included in this list and patients should be excluded accordingly at the surgeonsâ?? discretion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To record and analyze the profile and outcome of cataract patients receiving phacoemulsification and artificial intraocular lens implantation with or without femtosecond laser procedure in tertiary medical centers in India.Timepoint: Post Surgery day 1 and Post Surgery day 30 <br/ ><br>
- Secondary Outcome Measures
Name Time Method .A.Timepoint: N.A.