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Cataract surgery in Indian patients with or without LenSx laser.

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
.A.Timepoint: N.A.
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