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Manual Small Incision Cataract Surgery Outcomes in an Educational Setting (MSICS)

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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
Sponsor:
Information provided by (Responsible Party):
Joseph Miller, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Cataracts Procedure: Manual Small Incision Cataract Surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21 years or older (adults).
  2. Medically Stable, able to safely undergo surgery.
  3. Nuclear sclerotic cataract
  4. Preoperative best corrected visual acuity (BCVA) 20/80 or worse
  5. Expected post-operative potential acuity of 20/40 or better
  6. Able to pay the $500 cost of surgery at the time of surgery

Exclusion Criteria:

Potential subjects not satisfying any of the above


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277314


Contacts
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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

Locations
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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         
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Joseph M Miller, MD, PhD University of Arizona Department of Ophthalmology
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Responsible Party: Joseph Miller, Joseph Miller, MD, MPH, University of Arizona
ClinicalTrials.gov Identifier: NCT02277314    
Other Study ID Numbers: 1404277367
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases