Cataract Surgery in Indian Patients With or Without LenSx® Laser

NCT ID: NCT02605408

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataracts

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cataract surgery

Phacoemulsification and artificial IOL implantation with and without LenSx® laser system

LenSx® laser system

Intervention Type DEVICE

Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Phacoemulsification

Intervention Type PROCEDURE

Removal of the cataractous lens

Interventions

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LenSx® laser system

Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Intervention Type DEVICE

Phacoemulsification

Removal of the cataractous lens

Intervention Type PROCEDURE

Eligibility 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;

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;
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Head Medical Affairs, MD

Role: STUDY_DIRECTOR

Alcon India Pvt. Ltd.

Other Identifiers

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CTI742-P001

Identifier Type: -

Identifier Source: org_study_id

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