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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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

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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


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

Keywords provided by Innovative Medical:


Previous Cataract patients Monofocal IOL implant Evaluation

ClinicalTrials.gov processed this record on August 18, 2017

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