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Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye

NCT ID: NCT01161771

Last Updated: 2012-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

Brief Summary

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This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cataract and corneal astigmatism

Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)

Cataract Surgery and Limbal relaxing incision

Intervention Type PROCEDURE

Cataract extraction and limbal-relaxing incisions

Interventions

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Cataract Surgery and Limbal relaxing incision

Cataract extraction and limbal-relaxing incisions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

Exclusion Criteria

* Uncontrolled systemic disease
* Have undergone refractive surgery or any surgery involving a limbal or corneal incision
* Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
* Temporary or permanent occlusion of the lacrimal puncta
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Long Island City, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MA-RES-09-004

Identifier Type: -

Identifier Source: org_study_id