Trial record 3 of 29 for:    Open Studies | "Lenses, Intraocular"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Innovative Medical.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
STAAR Surgical
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01191515
First received: August 27, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 Intervention
Patients Implanted With Monofocal Intraocular Lens
Device: Monofocal Intraocular Lenses

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: 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
Other Name: Monofocal Intraocular Lenses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Glenn Campbell, MD Advanced Vision Institute
  More Information

No publications provided

Responsible Party: Innovative Medical, CRO
ClinicalTrials.gov Identifier: NCT01191515     History of Changes
Other Study ID Numbers: The Mast Study
Study First Received: August 27, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014