Comparison of Efficacy, Comfort and Ease of Application Between Four Methods of Eye Irrigation Trials Applied to Healthy Subjects.

A Summary of Study Data and Methods*

Prepared by: Northwest Physicians Research Network
101 East Broadway, Suite 610, Missoula, MT 59802


Principal Investigator:
Roger C. Furlong, M.D.
Rocky Mountain Eye & Ear Center, P. C
700 West Kent, Missoula, MT 59801


Study Sponsor:
MorTan, Inc.
P.O. Box 8719, Missoula, MT 59807

*This Summary has been modified and edited by MorTan, Inc.

--Entire study available upon request--

Note:

This test was sponsored by MorTan, Inc. under the direction of the Northwest Physicians Research Network (NPRN) with protocol review by Western Institutional Review Board (WIRB). Rocky Mountain Ear and Eye Center and subjects are not affiliated with MorTan, Inc. or the Northwest Physicians Research Network (NPRN).

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ABSTRACT

A group of nineteen healthy subjects underwent a series of four eye irrigation procedure trials using different techniques. Data was collected and compiled for each technique to compare the efficacy, ease of application, and subject comfort level of the different methods. Results showed that all techniques which used an inserted irrigating lens were more effective in the removal of foreign substance from the eye than the manual drip method¹. In addition, the Morgan® mor-FLEX® Lens (MT2000), a new MorTan product, earned high ratings in subject comfort, ease of use, and subject tolerance. These ratings, along with the new product's demonstrated efficacy, suggest that the Morgan mor-FLEX Lens offers an improved technique for the care of patients with eye trauma requiring irrigation treatment.

STUDY PROCEDURES

The study was done at the Rocky Mountain Ear and Eye Center, P.C., in Missoula, Montana. Subjects were enrolled in the study after screening to meet inclusion/exclusion criteria.

The irrigation techniques used were the currently available Morgan medi-FLOW® Lens (MT100) with anesthetic, the new Morgan mor-FLEX Lens (MT2000) without anesthetic (to simulate cases when no anesthetic is available), and the Morgan mor-FLEX Lens (MT2000) with anesthetic. Each of the methods of eye irrigation used Lactated Ringer's solution as the irrigation medium.

Before each irrigation procedure, a controlled amount of a foreign substance, approved for use in the eye (a prepared ophthalmic ointment mixed with a fluorescent dye), was put in the eye. A standardized amount of eye anesthetic was used in tests that called for it. One of the methods of eye irrigation, as determined by the defined trial pattern was then applied by a trained ophthalmic technician, using a standardized technique for the specified method. The procedure was observed by a study observer (Ophthalmologist). After the eye was irrigated with a defined volume of fluid (500 ml), the eye was examined under magnification and blue light to reveal any residual substance or post-procedure complication. The cornea, upper and lower conjunctival surfaces of the eyelid, and cul-de-sac areas were evaluated separately for residual foreign substance. The amount of remaining ocular lubricant noted in each eye region was rated and recorded separately by both the ophthalmologist and the ophthalmic technician. The eye was next checked for any evidence of complication resulting from the procedure (e.g. corneal abrasion). The efficacy of the irrigation procedure and the occurrence of post-procedure complications were the main parameters evaluated. The efficacy of the irrigation procedure

for each eye region was rated by both the ophthalmic technician and the ophthalmologist. Efficacy was rated for each designated region of the eye (corneal surface, upper and lower conjunctival surfaces of the eyelid and cul-de-sacs) by assessing the surface area of each given eye region remaining covered with dye-tinted ophthalmic ointment after irrigation. Scaled efficacy ratings were recorded, based on the surface area of each eye region remaining covered with ophthalmic ointment after irrigation.

The ease of use and the subject's tolerance of each irrigation method were also rated by both the ophthalmic technician and the ophthalmologist. The subjects also rated the comfort of each method.

1 Manual Drip irrigation was also tested. In this summary, however, the data on this method was deleted due to errors in clinical procedures: i.e. no attempt was made to keep the eyelids of the patients open during irrigation if patients were unable to hold the eye open unassisted.

The data was compiled, grouped by irrigation method and a comparative analysis was made. An average efficacy rating for each irrigation method in each separate region of the eye was calculated by adding the individual trial scores and dividing by the number of trials. An average overall efficacy for each method was then determined using the combined ratings of the individual eye regions. This overall efficacy rating may be considered in terms of the efficacy criteria to yield a descriptive idea of the method's efficacy. All evaluation scores for the irrigation method's ease of use of and the subject's tolerance or comfort were separately averaged into subject rated or ophthalmic technician and ophthalmologist rated scores for each irrigation method to provide for comparison. The different irrigation methods are compared on that basis.

RESULTS²

The MT100 medi-FLOW Lens (MT100) procedure was done with anesthetic. It earned an overall efficacy rating of 8.78 which relates to removal of approximately 95 to 99% of the foreign material in all areas of the eye. Subject comfort averaged 4.50 per individual which equals "minimal discomfort" to "very comfortable". The ease of use averaged 4.47 which equals "moderate" to "very easy/prefer to use". The same pattern was seen in the subject tolerance area which averaged 4.03, equal to, "procedure accepted with slight signs of minimal discomfort".

The MT2000 mor-FLEX Lens without anesthetic technique showed a good efficacy result in subjects who tolerated the procedure, earning a rating of 8.88. This is the highest efficacy score found, although the spread of scores for the top three ratings was too close to indicate a practical difference in efficacy.

It is also noteworthy that the efficacy data excludes subjects who were unable to tolerate the procedure. Three subjects were unable to tolerate use of the irrigating lens without anesthetic³. Average score for subject comfort (excluding those three unable to tolerate) was 4.03, ease of application was 4.19, and subject tolerance was 4.26.

Data for the efficacy of the MT2000 mor-FLEX Lens with anesthetic technique is similar to that found in the other trial of the MT2000 mor-FLEX Lens. An efficacy score of 8.50 was earned. This falls within the close group of the top three scores for this parameter, and indicates a comparable practical performance in the removal of foreign substance. Parameters of subject comfort, ease of application and subject tolerance for this procedure all earned scores practically equivalent to the highest scores found for any technique. Subject comfort averaged 4.94. Ease of use and subject tolerance earned averages of 4.72 and 4.80 respectively.

Subjects were closely monitored for adverse events and side effects from the procedures. There were no serious adverse events, or any that required either follow up or rescue treatment.

A side effect of one corneal abrasion was noted. The event was judged to be related to trial procedure. This abrasion resolved spontaneously and had a minimal impact on the subject. The event occurred during a trial of the MT100 medi-FLOW Lens. Fifty-three percent of the procedures produced SPK (superficial punctate keratitis), including the manual drip technique where no device was inserted onto the eye. This raises the possibility of a relationship between SPK findings and the foreign substance or irrigation fluid. In any case, this finding was of minimal significance in terms of outcome, given the spontaneous resolution of the effect and its minor impact on the subjects.

2 See chart.

3 One subject was unable to open eyes, two subjects could not tolerate fluid flow - one stating "too much fluid", and one "fluid too cold". It should be noted that since atraumatic eyes were tested, any reluctance by the patient resulted in immediate termination of the testing.

CONCLUSIONS

The implications of the study results in regard to patient care comprise the basis for the conclusions. The data regarding the trials of the MT2000 mor-FLEX Lens without anesthetic is clearly significant. While this procedure was effective in subjects who tolerated it, three procedures were halted due to subject intolerance. For subjects who tolerated the procedure, the scored parameters expressed lower rates of comfort, ease of application and tolerance. This evidence indicates that most individuals will do better with a topical anesthetic. (However, 84% of the non-anesthetic subjects scored over 4.0 in each category.)

The MT100 medi-FLOW Lens system, used with anesthetic, was shown to be effective in removal of foreign substance in this trial. The average efficacy rating correlated with the

removal of approximately 95 to 99% of the foreign substance introduced using a volume of 500 ml irrigating solution. This was the volume of irrigation fluid selected for the trial procedures. Treatment of actual eye patients would likely require more irrigation to insure total removal of all foreign substance, but the trial procedures used are adequate for efficacy comparison of the techniques. The subject comfort, ease of use and subject tolerance ratings for the medi-FLOW system are lower than those found for the MT2000 mor-FLEX Lens technique, used with eye anesthetic.

When employed with anesthetic, the MT2000 mor-FLEX Lens technique offers an efficacy comparable to the MT100 medi-FLOW Lens, earning an overall score correlated with the removal of 95 to 99% of the introduced foreign substance in the trials. When this data is considered along with the technique's high ratings in comfort, ease of use and tolerance, the evidence suggests the MT2000 mor-FLEX Lens represents a significant opportunity for improved patient care.

SUBJECT COMFORT SCORE:

AVERAGE SCORES BY IRRIGATION METHOD

 

SUBJECT REPORT

Patients were asked to rate the comfort of the irrigation procedure they had on a scale of 1 to 5 using the following rating scale:

5 - Very comfortable, pain free, subject would recommend this treatment to others

4 - Minimal discomfort with procedure, easily bearable, subject would readily accept this treatment again if needed

3 - Moderate discomfort with procedure, subject would accept this treatment only if no

other option was available and then only with pain control medication

2 - Great discomfort with pain during procedure, bearable with extreme difficulty, subject would refuse this treatment if offered again

1- Intolerable discomfort with pain, procedure halted due to intolerance







EASE OF APPLICATION & SUBJECT TOLERANCE SCORE:OPHTHALMOLOGIST & TECHNICIAN AVERAGE SCORES BY IRRIGATION METHOD

Rating scales used for the above charts are shown on the next page.

The ophthalmic technician evaluated the ease of use and made an observation of the level of acceptance for each irrigation trial. Ease of use was rated by these criteria:

5 - Very easy to use, care giver would always prefer to use this method and recommend it

4 - Moderately easy to use, care giver would prefer this method in most cases

3 - Usable, preferred equally with other methods

2 - Moderately difficult to use, care giver would prefer other methods in most cases

1 - Very difficult to use, care giver would seek alternative means in all cases

The technician evaluated the level of subject tolerance for each irrigation trial using these criteria:

5 - Procedure well accepted, no discomfort or pain noted

4 - Procedure accepted with slight signs of minimal discomfort

3 - Procedure accepted, signs of discomfort and pain with procedure noted

2 - Procedure not well tolerated, verbal and physical signs of difficulty noted

1 - Procedure terminated due to subject intolerance and pain

The technician recorded the observations immediately after the objective assessments were made. Both the objective and subjective data were recorded on the same form.

AVERAGE EFFICACY RATING BY EYE REGIONS:
TECHNICIAN AND OPHTHALMOLOGIST RATINGS BY IRRIGATION TECHNIQUES

Rating scale for the above chart is located on the following page.

A defined rating scale from 1 to 10 was used to record the efficacy, with ratings assigned according to these criteria:

10 - No trace of foreign substance remaining.

9 - Visible traces of foreign substance present without sufficient quantity to estimate surface area covered. Less than 1% of the eye surface area shows foreign substance remaining.

8 - Amount of foreign substance remaining covers 1 to 10% of the eye surface area.

7 - Amount of foreign substance remaining covers 11 to 20% of the eye surface area.

6 - Amount of foreign substance remaining covers 21 to 30% of the eye surface area.

5 - Amount of foreign substance remaining covers 31 to 40% of the eye surface area.

4 - Amount of foreign substance remaining covers 41 to 50% of the eye surface area.

3 - Amount of foreign substance remaining covers 51 to 60% of the eye surface area.

2 - Amount of foreign substance remaining covers 61 to 70% of the eye surface area.

1 - Amount of foreign substance remaining covers over 70% of the eye surface area.

The technician assessed the subject first, followed by the ophthalmologist. Charts illustrating defined percentages of the eye surface area were used as a guide to standardize the observations. The technician and ophthalmologist were trained in the rating procedure.