Manual Small Incision Cataract Surgery Outcomes in an Educational Setting (MSICS)
|ClinicalTrials.gov Identifier: NCT02277314|
Recruitment Status : Unknown
Verified January 2016 by Joseph Miller, University of Arizona.
Recruitment status was: Recruiting
First Posted : October 29, 2014
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cataracts||Procedure: Manual Small Incision Cataract Surgery||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Manual Small Incision Cataract Surgery Outcomes in an Educational Setting|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Low Cost Treatment for Cataracts
Low cost, manual small incision cataract surgery performed in an educational environment. All costs covered by subjects.
Procedure: Manual Small Incision Cataract Surgery
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 Name: MSICS
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277314
|Contact: Sue A Bulau, BA, AAS||520-694-1421||SueAnnBulau@uahealth.com|
|Contact: Jill E Brickman-Kelleher, BS, AAS||520-694-1471||Jill.Brickman-Kelleher@uahealth.com|
|United States, Arizona|
|University of Arizona Medical Center Alvernon Physician Offices||Recruiting|
|Tucson, Arizona, United States, 85711|
|Contact: Sue A Bulau, BA, AAS 520-694-1421 SueAnnBulau@uahealth.com|
|Contact: Jill E Brickman-Kelleher, BS, AAS 520-694-1471 Jill.Brickman-Kelleher@uahealth.com|
|Principal Investigator: Joseph P Miller, MD, MPH|
|Principal Investigator:||Joseph M Miller, MD, PhD||University of Arizona Department of Ophthalmology|