NCT01191515

Brief Summary

The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

August 27, 2010

Last Update Submit

June 13, 2012

Conditions

Patients Implanted With Monofocal Intraocular Lens

Keywords

Previous Cataract patientsMonofocal IOL implantEvaluation

Study Arms (2)

Near visual outcomes with Monofocal IOL

Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye.

Device: Monofocal Intraocular Lenses

Intermediate Visual outcomes

Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye.

Device: Monofocal Intraocular Lenses

Interventions

Monofocal Intraocular LensesDEVICE

Monofocal Intraocular Lenses

Intermediate Visual outcomesNear visual outcomes with Monofocal IOL

Eligibility Criteria

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

Prospective evaluation of 200 patients male or female at least 18 years of age who have previously undergone phacoemulsification (the break-up and removal of a cataract) between one and 36 months earlier

You may qualify if:

  • Male or female patients at least 18 years of age
  • Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
  • At least 1 month postop before follow-up evaluation
  • All Patients must have a DCVA of 20/25 or better

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Vision Institute

Williamsburg, Virginia, 23188, United States

RECRUITING

Study Officials

  • Glenn Campbell, MD

    Advanced Vision Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Piel

CONTACT

(951)653-5566j.piel@imedsonline.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)