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

University of Arizona

Status: Unknown

Conditions: Cataracts

Treatments: Procedure: Manual Small Incision Cataract Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02277314

1404277367

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Low Cost Treatment for Cataracts

Other group

Description:

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

Treatment:

Procedure: Manual Small Incision Cataract Surgery