NCT02058394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

February 4, 2014

Last Update Submit

February 6, 2014

Conditions

Cataract

Keywords

Retained nuclear lens fragmentsPhacoemulsificationCataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Macular edema

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

    1 month postoperatively

Secondary Outcomes (7)

  • Intraocular inflammation

    1 month postoperativley

  • Elevated intraocular pressure

    1 month postoperatively

  • Macular Edema

    1 week postoperatively

  • Intraocular Inflammation

    1 week postoperatively

  • Elevated Intraocular Pressure

    1 week postoperatively

  • +2 more secondary outcomes

Other Outcomes (1)

  • Surgical Complications

    Intraoperatively

Study Arms (1)

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

Interventions

PhacoemulsificationPROCEDURE

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

Cataract Phacoemulsification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Routine cataract surgery with phacoemulsification

You may not qualify if:

  • Pre-existing macular edema
  • Active uveitis
  • Significant ocular trauma
  • Evidence of phacodonesis or zonular weakness .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • David Ritterband, MD

    Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 10, 2014

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

US(1)