Retained Lens Fragments After Phacoemulsification

NCT ID: NCT02058394

Last Updated: 2014-02-10

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.

Detailed Description

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In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cataract Phacoemulsification

Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Phacoemulsification

Intervention Type PROCEDURE

Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Interventions

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Phacoemulsification

Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Routine cataract surgery with phacoemulsification

Exclusion Criteria

* Pre-existing macular edema
* Active uveitis
* Intraocular exclusion surgeries
* Significant ocular trauma
* Evidence of phacodonesis or zonular weakness .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

OTHER

Sponsor Role lead

Responsible Party

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David Ritterband

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ritterband, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC

Locations

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Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12.08

Identifier Type: -

Identifier Source: org_study_id

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