NCT00406263

Brief Summary

Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

November 30, 2006

Last Update Submit

July 25, 2016

Conditions

Keywords

nuclear sclerotic cataractcataract

Interventions

scheimpflug photographs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing vitrectony surgery and controls

You may qualify if:

  • phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
  • controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
  • age 18 and older

You may not qualify if:

  • any eye that is pseudophakic,
  • has had previous vitreoretinal surgery,
  • has had previous intravitreal injection,
  • previous intraocular inflammatory condition such as uveitis,
  • previous irradiation,
  • any patient with a history of ocular malignancy,
  • history of infectious intraocular condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Nancy M Holekamp, MD

    Barnes Retina Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nancy Holekamp, MD, Principal Investigator

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations