Manual Small Incision Cataract Surgery Outcomes in an Educational Setting
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | April 2016 |
| Contact: | Sue A Bulau, BA, AAS |
| Email: | SueAnnBulau@uahealth.com |
| Phone: | 520-694-1421 |
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.
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.
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.
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.
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
We found this trial at
1
site
Tucson, Arizona 85711
Principal Investigator: Joseph P Miller, MD, MPH
Phone: 520-694-1421
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