Retained Lens Fragments After Phacoemulsification

February 6, 2014 updated by: David Ritterband, Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cataract Phacoemulsification
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
Procedure: Phacoemulsification
Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular edema
Time Frame: 1 month postoperatively
Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively
1 month postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Complications
Time Frame: Intraoperatively
Proportion of eyes with surgical adverse events.
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

Investigators

  • Principal Investigator: David Ritterband, MD, Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Phacoemulsification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe