Retained Lens Fragments After Phacoemulsification

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification

• Registration Number: NCT02058394
• Lead Sponsor: Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-10
• Last Update Posted: 2014-02-10
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract 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 Outcome Measures

Name	Time	Method
Macular edema	1 month postoperatively	Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively

Secondary Outcome Measures

Name	Time	Method
Intraocular inflammation	1 month postoperativley	Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively
Elevated intraocular pressure	1 month postoperatively	Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively
Macular Edema	3 months postoperatively	Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively
Intraocular Inflammation	3 months	Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively
Elevated Intraocular Pressure	1 week postoperatively	Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively

Trial Locations

Locations (1)

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC; 🇺🇸 New York, New York, United States