Retained Lens Fragments After Phacoemulsification

Sponsor
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC (Other)
Overall Status
Unknown status
CT.gov ID
NCT02058394
Collaborator
(none)
500
Enrollment
1
Location
36
Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Phacoemulsification

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
Study Start Date :
Mar 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Mar 1, 2015

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Intraocular inflammation [1 month postoperativley]

    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 month postoperatively

  2. Elevated intraocular pressure [1 month postoperatively]

    Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 month postoperatively

  3. Macular Edema [1 week postoperatively]

    Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 week postoperatively

  4. Intraocular Inflammation [1 week postoperatively]

    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 1 week postoperatively

  5. Elevated Intraocular Pressure [1 week postoperatively]

    Proportion of eyes with intraocular pressure increase requiring medical or surgery treatment at 1 week postoperatively

  6. Macular Edema [3 months postoperatively]

    Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 3 months postoperatively

  7. Intraocular Inflammation [3 months]

    Proportion of eyes with persistent anterior chamber inflammation requiring medical treatment at 3 months postoperatively

Other Outcome Measures

  1. Surgical Complications [Intraoperatively]

    Proportion of eyes with surgical adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PCNew YorkNew YorkUnited States10003

Sponsors and Collaborators

  • Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Ritterband, MD, Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
ClinicalTrials.gov Identifier:
NCT02058394
Other Study ID Numbers:
  • 12.08
First Posted:
Feb 10, 2014
Last Update Posted:
Feb 10, 2014
Last Verified:
Feb 1, 2014
Keywords provided by David Ritterband, MD, Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2014