Manual Small Incision Cataract Surgery Outcomes in an Educational Setting (MSICS)
Primary Purpose
Cataracts
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Small Incision Cataract Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
Inclusion Criteria:
- Age 21 years or older (adults).
- Medically Stable, able to safely undergo surgery.
- Nuclear sclerotic cataract
- Preoperative best corrected visual acuity (BCVA) 20/80 or worse
- Expected post-operative potential acuity of 20/40 or better
- Able to pay the $500 cost of surgery at the time of surgery
Exclusion Criteria:
Potential subjects not satisfying any of the above
Sites / Locations
- University of Arizona Medical Center Alvernon Physician OfficesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Low Cost Treatment for Cataracts
Arm Description
Low cost, manual small incision cataract surgery performed in an educational environment. All costs covered by subjects.
Outcomes
Primary Outcome Measures
Manual Small Incision Cataract Surgery with outcomes of 20/40 or better at the end of a year and with spectacle correction
Post-cataract surgery the subject must have a visual acuity of 20/40 or better with spectacle correction
Secondary Outcome Measures
Full Information
NCT ID
NCT02277314
First Posted
October 24, 2014
Last Updated
January 11, 2016
Sponsor
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT02277314
Brief Title
Manual Small Incision Cataract Surgery Outcomes in an Educational Setting
Acronym
MSICS
Official Title
Manual Small Incision Cataract Surgery Outcomes in an Educational Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective is to determine the visual outcomes and cost to perform Manual Small Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the United States. The primary outcome measure will be the percentage of the study group achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed in academic centers. A secondary outcome will be to determine the actual institutional cost of providing MSICS in the setting of an academic medical center. The hypothesis is that MSICS is appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or better at 90 days post op, as compared to PCS), and can be provided at a cost that makes visual rehabilitation affordable to the uninsured and underinsured.
Detailed Description
The investigator will perform a study of a pilot implementation of portions of the Aravind method of promoting access to care and provision of surgical services in the setting of an academic medical center teaching program. Target enrollment is 100 subjects having cataracts. Potential subjects will be identified through vision screening programs and if cataracts are found they will be offered MSICS at a price deemed to be affordable by individuals without insurance.
A survey of Pima County providers found that $3500 was the lowest price offered to a self-pay patient for one-stage cataract extraction (CPT 66984) for PCS facility fee, surgeon fee, and anesthesia fee. The expectation is that MSICS can be delivered in a teaching environment at a cost of $500. The investigator wishes to determine if this price point is sustainable and if a continuing model of cataract visual rehabilitation service delivery can be safely, affordably, and ethically delivered to those who cannot afford to pay, while integrating resident education and autonomy into the delivery model.
The proposed outcome measure is the proportion of eyes that see 20/40 or better while wearing glasses for those participants that do not have comorbid conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Cost Treatment for Cataracts
Arm Type
Other
Arm Description
Low cost, manual small incision cataract surgery performed in an educational environment. All costs covered by subjects.
Intervention Type
Procedure
Intervention Name(s)
Manual Small Incision Cataract Surgery
Other Intervention Name(s)
MSICS
Intervention Description
This cost-effective solution for removing cataracts, also known as Manual Small Incision Cataract Surgery (MSICS), is a positive alternative when Phaco is not an option due to costs. The procedure takes approximately 30 minutes and involves a mid-size incision and an intraocular lens (IOL), or artificial lens, replacing the natural lens. Following the procedure, patients may need glasses, and most will need bifocals, but overall vision will be significantly improved.
Primary Outcome Measure Information:
Title
Manual Small Incision Cataract Surgery with outcomes of 20/40 or better at the end of a year and with spectacle correction
Description
Post-cataract surgery the subject must have a visual acuity of 20/40 or better with spectacle correction
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 21 years or older (adults).
Medically Stable, able to safely undergo surgery.
Nuclear sclerotic cataract
Preoperative best corrected visual acuity (BCVA) 20/80 or worse
Expected post-operative potential acuity of 20/40 or better
Able to pay the $500 cost of surgery at the time of surgery
Exclusion Criteria:
Potential subjects not satisfying any of the above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sue A Bulau, BA, AAS
Phone
520-694-1421
Email
SueAnnBulau@uahealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jill E Brickman-Kelleher, BS, AAS
Phone
520-694-1471
Email
Jill.Brickman-Kelleher@uahealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Miller, MD, PhD
Organizational Affiliation
University of Arizona Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center Alvernon Physician Offices
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue A Bulau, BA, AAS
Phone
520-694-1421
Email
SueAnnBulau@uahealth.com
First Name & Middle Initial & Last Name & Degree
Jill E Brickman-Kelleher, BS, AAS
Phone
520-694-1471
Email
Jill.Brickman-Kelleher@uahealth.com
First Name & Middle Initial & Last Name & Degree
Joseph P Miller, MD, MPH
12. IPD Sharing Statement
Learn more about this trial
Manual Small Incision Cataract Surgery Outcomes in an Educational Setting
We'll reach out to this number within 24 hrs