Overview

This trial is active, not recruiting.

Condition cataract
Treatment phacoemulsification
Sponsor Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC
Start date March 2012
End date December 2014
Trial size 500 participants
Trial identifier NCT02058394, 12.08

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
phacoemulsification
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Primary Outcomes

Measure
Macular edema
time frame: 1 month postoperatively

Secondary Outcomes

Measure
Intraocular inflammation
time frame: 1 month postoperativley
Elevated intraocular pressure
time frame: 1 month postoperatively
Macular Edema
time frame: 1 week postoperatively
Intraocular Inflammation
time frame: 1 week postoperatively
Elevated Intraocular Pressure
time frame: 1 week postoperatively
Macular Edema
time frame: 3 months postoperatively
Intraocular Inflammation
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 .

Additional Information

Official title Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
Principal investigator David Ritterband, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC.