Retained Lens Fragments After Phacoemulsification

Cataract Clinical Trial

Official title:

Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02058394
• Other study ID #: 12.08
• Status: Active, not recruiting
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 6, 2014
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
United States	Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmic Consultants, Corneal and Refractive Surgery Assoicates, PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical Complications	Proportion of eyes with surgical adverse events.	Intraoperatively	Yes
Primary	Macular edema	Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively	1 month postoperatively	No
Secondary	Intraocular inflammation	Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively	1 month postoperativley	No
Secondary	Elevated intraocular pressure	Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively	1 month postoperatively	No
Secondary	Macular Edema	Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively	1 week postoperatively	No
Secondary	Intraocular Inflammation	Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively	1 week postoperatively	No
Secondary	Elevated Intraocular Pressure	Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively	1 week postoperatively	No
Secondary	Macular Edema	Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively	3 months postoperatively	No
Secondary	Intraocular Inflammation	Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively	3 months	No