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Clinical Trials/NCT02058394
NCT02058394
Unknown
N/A

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

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC1 site in 1 country500 target enrollmentMarch 2012
ConditionsCataract

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cataract
Sponsor
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
Enrollment
500
Locations
1
Primary Endpoint
Macular edema
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2015
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
Responsible Party
Principal Investigator
Principal Investigator

David Ritterband

MD

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

Eligibility Criteria

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 .

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Intraocular inflammation(1 month postoperativley)
  • Elevated intraocular pressure(1 month postoperatively)
  • Macular Edema(3 months postoperatively)
  • Intraocular Inflammation(3 months)
  • Elevated Intraocular Pressure(1 week postoperatively)

Study Sites (1)

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