Manual Small Incision Cataract Surgery Outcomes in an Educational Setting

Cataracts Clinical Trial

— MSICS  

Official title:

Manual Small Incision Cataract Surgery Outcomes in an Educational Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277314
• Other study ID #: 1404277367
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2014
• Last updated: January 11, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: University of Arizona
• Contact: Sue A Bulau, BA, AAS
• Phone: 520-694-1421
• Email: SueAnnBulau[@]uahealth.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona Medical Center Alvernon Physician Offices	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No