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
Recruitment status was Recruiting
Sponsor:
Innovative Medical
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
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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
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 March 03, 2015