results

RESULTS (UK) Pilot Programme

(posted 15 December 2004)

FAQ about RESULTS

RESULTS Programme Outline

FAQ about RESULTS

What is RESULTS?

RESULTS is an innovative method to validate the safety and efficacy of corneal laser refractive surgery, at the level of your specific practice. Our aim in pioneering RESULTS is (a) to provide a way for refractive surgeons to demonstrate more effectively the quality of their services through increased transparency and “open-book” outcome tracking and (b) to provide a way for consumers to better educate themselves about the benefits and risks of laser eye surgery.

Why is this the right time for RESULTS?

Laser eye surgery is under close scrutiny in the UK. The National Institute for Clinical Excellence has issued a guidance about LASIK, and the Parliamentary panel on laser eye surgery is releasing its report with recommendations for increased regulation. These publications may increase patient anxiety.

One of LaserMyEye’s foremost goals is consumer education which, to be effective, must be relevant, balanced, unbiased and above all fact-based. Too often public information on laser eye surgery is polarised, distorted in one direction by advertising which minimises risks and sets inappropriate expectations and in another by popular press reports and “horror stories”.

In such an environment, it is increasingly difficult for potential patients to identify refractive surgeons who are truly “among the best” in the field - those whose clinical and surgical treatment consistently leads to the desired reduction in refractive error, minimal loss of low-light vision quality, minimal ocular surface disturbance, a low complication rate and a low retreatment rate.

RESULTS is a tool for you to communicate to prospective patients your commitment to excellence and your willingness to audit your results. They will also learn about vision quality and ocular surface concerns, and thus hopefully arrive at your clinic with educated expectations.

What additional clinical effort is required by RESULTS?

We support the concept that high-contrast visual acuity is inadequate as a sole measurement of the safety and efficacy of laser refractive surgery. Therefore, in addition to traditional parameters (pre-operative best corrected visual acuity, post-operative best corrected visual acuity, post-operative uncorrected visual acuity, achieved reduction in refractive error vs intended reduction, complication and re-treatment rates), RESULTS uses two validated psychometric surveys (Ocular Surface Disease Index and Fraenkel-Lawless Subjective Vision Score) to measure the effect of surgery on dry eye symptoms and on visual function, particularly low-light function (Schiffman RM, Et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May; 118(5):615-21. Fraenkel G., Et al. Development of a questionnaire to assess subjective vision score in myopes seeking refractive surgery. J Refract Surg. 2004 Jan-Feb; 20(1):10-9.).

How can I subscribe to RESULTS?

Contact Rebecca Petris (rebecca@lasermyeye.org).

RESULTS Programme Outline

Synopsis:

RESULTS is a collaborative programme between laser eye surgeons or clinics and LaserMyEye, Inc. (a consumer group) to implement unified standards for assessing and tracking safety and efficacy of laser eye surgery procedures. Under RESULTS, changes to visual acuity, vision quality, and ocular surface health are measured in laser eye surgery patients and rates of retreatment and complications are tracked statistically.

RESULTS consists of three progressively demanding phases. Clinics may elect to subscribe to the phase they choose, without further obligation. Phase I involves the adoption of the outlined assessment methodology. Phase II adds reporting and publication of the results. Phase III adds to these a periodic in-clinic audit.

Phase I: Basic subscription to tracking standards

Clinic obligations:

1. Procedures for RESULTS compliance are established by the medical director. These procedures must include (but need not be limited to) the following:

a. The following tests or surveys are administered to all patients prior to a primary laser refractive procedure and six months afterwards, and basic statistics for each are compiled:

Refraction, uncorrected and best-corrected visual acuity
Fraenkel-Lawless vision function questionnaire
Ocular Surface Disease Index questionnaire

b. Incidence of complications is statistically tracked for each six month period, including but not limited to: flap complications (short, buttonhole, rotation, free cap, etc), DLK, epithelial ingrowth and corneal ectasia.

c. Retreatment rates are statistically tracked for each six month period.

(Note: User-friendly software will be provided to the clinic for compliance unless the clinic already has software that meets the requirements described.)

2. A clinic employee is designated for RESULTS compliance.

3. A single-page report in a standard format provided to the clinic is completed and sent to LaserMyEye semi-annually (subject to a confidentiality agreement). This report indicates the period, the number of primary surgical treatments undertaken during that period and of those the number of patients who completed the requisite tests, the number of patients reaching the 6-month follow-up point during that period and of those the number who completed the requisite tests, and confirming that statistics are being tracked for the outcomes, complications and retreatments. The report is signed by the designated compliance employee and by the medical director and certifies that the information is correct to the best of their knowledge.

4. Statistics in each of the required areas are made available by the clinic on request to prospective patients visiting the clinic.

Phase II: Results reporting

Clinic obligations, in addition to those outlined in Phase I:

1. Report data collected in Phase I to LaserMyEye on a semi-annual basis in a standard form to be provided.

2. Publish basic statistics on the clinic’s website and in printed materials provided to prospective patients.

Phase III: Records audit

Clinic obligation, in addition to those outlined in Phases I and II: Undergo a random in-clinic records audit not less than annually, provided by a LaserMyEye representative.

Costs:

There are no professional fees associated with subscribing to the RESULTS scheme. Subscription to Phase III will entail reimbursement of direct expenses (e.g. travel).