Manual Small Incision Cataract Surgery Outcomes in an Educational Setting

NCT02277314 | Unknown

• 1 other identifier: 1404277367
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

Low Cost Treatment for Cataracts

OTHER

Low cost, manual small incision cataract surgery performed in an educational environment. All costs covered by subjects.

Procedure: Manual Small Incision Cataract Surgery

Interventions

Manual Small Incision Cataract Surgery PROCEDURE

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.

Also known as: MSICS

Low Cost Treatment for Cataracts

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Potential subjects not satisfying any of the above

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Medical Center Alvernon Physician Offices

Tucson, Arizona, 85711, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Joseph M Miller, MD, PhD

  University of Arizona Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue A Bulau, BA, AAS

CONTACT

520-694-1421; SueAnnBulau@uahealth.com

Jill E Brickman-Kelleher, BS, AAS

CONTACT

520-694-1471; Jill.Brickman-Kelleher@uahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joseph Miller, MD, MPH

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)