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Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

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ClinicalTrials.gov Identifier: NCT01191515
Recruitment Status : Unknown
Verified June 2012 by Innovative Medical.
Recruitment status was:  Recruiting
First Posted : August 30, 2010
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
Staar Surgical Company
Information provided by:
Innovative Medical

Study Description
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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.

Condition or disease Intervention/treatment
Patients Implanted With Monofocal Intraocular Lens Device: Monofocal Intraocular Lenses

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
Study Start Date : August 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
Monofocal Intraocular Lenses


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191515


Contacts
Contact: Jennifer Piel (951)653-5566 j.piel@imedsonline.com

Locations
United States, Virginia
Advanced Vision Institute Recruiting
Williamsburg, Virginia, United States, 23188
Principal Investigator: Glenn Campbell, MD         
Sponsors and Collaborators
Innovative Medical
Staar Surgical Company
Investigators
Principal Investigator: Glenn Campbell, MD Advanced Vision Institute
More Information
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Responsible Party: Innovative Medical, CRO
ClinicalTrials.gov Identifier: NCT01191515     History of Changes
Other Study ID Numbers: The Mast Study
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Innovative Medical:
Previous Cataract patients
Monofocal IOL implant
Evaluation