- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277314
Manual Small Incision Cataract Surgery Outcomes in an Educational Setting (MSICS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85711
- Recruiting
- University of Arizona Medical Center Alvernon Physician Offices
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Contact:
- Sue A Bulau, BA, AAS
- Phone Number: 520-694-1421
- Email: SueAnnBulau@uahealth.com
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Contact:
- Jill E Brickman-Kelleher, BS, AAS
- Phone Number: 520-694-1471
- Email: Jill.Brickman-Kelleher@uahealth.com
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Principal Investigator:
- Joseph P Miller, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Low Cost Treatment for Cataracts
Low cost, manual small incision cataract surgery performed in an educational environment.
All costs covered by subjects.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual Small Incision Cataract Surgery with outcomes of 20/40 or better at the end of a year and with spectacle correction
Time Frame: 2 years
|
Post-cataract surgery the subject must have a visual acuity of 20/40 or better with spectacle correction
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph M Miller, MD, PhD, University of Arizona Department of Ophthalmology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1404277367
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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