Recruiting

Observational Study

Sponsor:

University of Arizona

Code:

NCT02277314

Conditions

Cataracts

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Manual Small Incision Cataract Surgery

Study Details

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

Study ID

NCT02277314

Start date

Apr, 2014

Status verified date

Jan, 2016

Completion date

Apr, 2016

Anticipated

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Low Cost Treatment for Cataracts

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

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sue A Bulau, BA, AAS

520-694-1421SueAnnBulau@uahealth.com

Jill E Brickman-Kelleher, BS, AAS

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

Locations

University of Arizona Medical Center Alvernon Physician Offices

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Sue A Bulau, BA, AAS

520-694-1421SueAnnBulau@uahealth.com

Jill E Brickman-Kelleher, BS, AAS

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

Principal Investigator:

Joseph P Miller, MD, MPH

More Information

Sponsor

University of Arizona

Last update posted

Jan 13, 2016

Last verified

Jan, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2016-01-13.