Identification of contact lens wearers predisposed to contact lens discomfort

Patent metadata

Field	Value
Publication number	US-11317797-B2
Application number	US-201616062621-A
Country	US
Kind code	B2
Filing date	Dec 20, 2016
Priority date	Dec 28, 2015
Publication date	May 3, 2022
Grant date	May 3, 2022

Abstract

A method of determining a predisposition to contact lens discomfort in a patient is provided, comprising determining a detection threshold of the patient by delivering a cool mechanical stimulus to the cornea of the patient, optionally applying a series of cool mechanical stimuli to the cornea of the patient, and classifying the patient as being predisposed to contact lens discomfort if the detection threshold is at or below a cut-off value predetermined to be associated with predisposition to contact lens discomfort and/or the patient does not adapt to the series of cool mechanical stimuli.

First claim

What is claimed is:

1. A method of determining a predisposition to contact lens discomfort in a patient, said method comprising:
determining a detection threshold of the patient by delivering a cool mechanical stimulus to the cornea of the patient;
optionally applying a series of cool mechanical stimuli to the cornea of the patient; and
classifying the patient as being predisposed to contact lens discomfort if
(i) the detection threshold is at or below a cut-off value predetermined to be associated with predisposition to contact lens discomfort,
(ii) the patient does not adapt to the series of cool mechanical stimuli, or
(iii) the detection threshold is at or below a cut-off value predetermined to be associated with predisposition to contact lens discomfort and the patient does not adapt to the series of cool mechanical stimuli.

2. The method of claim 1 , comprising applying a series of cool mechanical stimuli to the cornea of the patient and classifying the patient as being predisposed to contact lens discomfort if the patient does not adapt to the series of cool mechanical stimuli.

3. The method of claim 1 , wherein the cool mechanical stimulus is delivered by directing a cool fluid to the cornea of the patient.

4. The method of claim 3 , wherein the cool fluid is a gas.

5. The method of claim 3 , wherein the cool fluid is a liquid.

6. The method of claim 2 , wherein the cool mechanical stimulus is a cool pneumatic stimulus and the series of cool mechanical stimuli is a series of cool pneumatic stimuli.

7. The method of claim 6 , wherein the cool pneumatic stimulus is delivered by a pneumatic esthesiometer.

8. The method of claim 6 , wherein the cool pneumatic stimulus is delivered at about room temperature.

9. The method of claim 6 , wherein the cool pneumatic stimulus is delivered to the cornea at a controlled flow rate having a temperature of from about 20° C. to 30° C. from an air pulse source located at a controlled spaced-apart distance of from 1 mm to 10 mm from the cornea for a controlled duration of from 1 second to 5 seconds.

10. The method of claim 6 , wherein the cool pneumatic stimulus is delivered as ascending intensities of air pulse flow rates, with a pause between deliveries of different air pulse flow rates, until an air pulse flow rate elicits a positive psychophysical response from the patient, wherein said air pulse flow rate that elicits the positive psychophysical response from the patient is used to determine the patient's detection threshold.

11. The method of claim 6 , wherein the series of cool pneumatic stimuli is applied to the cornea of the patient and the patient is classified as being predisposed to contact lens discomfort if the patient does not adapt to the series of cool pneumatic stimuli.

12. The method of claim 11 , wherein the series of cool pneumatic stimuli is applied at subthreshold intensity.

13. The method of claim 11 , wherein the series of cool pneumatic stimuli is applied at threshold intensity.

14. The method of claim 11 , wherein the series of cool pneumatic stimuli is applied at suprathreshold intensity.

15. The method of claim 11 , wherein the patient is prescribed initial contact lenses after the detection threshold is determined and the series of cool pneumatic stimuli is applied to the patient after the initial contact lenses have been worn by the patient for at least one day.

16. The method of claim 15 , further comprising prescribing contact lenses comprising a different design and/or material from the initial contact lenses if the patient does not adapt to the series of cool pneumatic stimuli.

17. The method of claim 2 , wherein the detection threshold or the patient's ability to adapt to the series of cool mechanical stimuli are determined prior to prescribing contact lenses to the patient.

18. The method of claim 1 , wherein the patient is one of a neophyte contact lens wearer, a current contact lens wearer and a lapsed contact lens wearer.

19. The method of claim 1 , further comprising including the patient as a subject in a clinical trial for a pre-marketed contact lens.

20. The method of claim 1 , wherein classifying the patient comprises inputting results of the determining step into a system comprising a controller configured to i) receive the results; ii) optionally receive data on whether the patient adapts to a series of cool mechanical stimuli administered to an ocular surface of the patient; and iii) classify the patient as being predisposed to contact lens discomfort if the patient's detection threshold is below a predetermined cut-off associated with predisposition to contact lens discomfort and/or if the patient does not adapt to the series of cool mechanical stimuli.

21. The method of claim 20 , wherein the controller carries out the additional step of iv) outputting a recommendation for the patient's follow-up management based on the patient's classification.

22. The method of claim 21 , wherein the patient is classified as being predisposed to contact lens discomfort and the recommendation for the patient's follow-up management comprises at least one of prescribing a premium lens to the patient, prescribing an ophthalmic drop that promotes ocular comfort, and scheduling a follow-up visit for the patient.

23. An analysis system comprising:
an esthesiometer comprising a source of fluid, a fluid flow rate controller coupled to the source of fluid, a tip coupled to the flow rate controller adapted to deliver a cool mechanical stimulus to an ocular surface of a patient, and a user input device by which patient responses can be signaled; and
a controller in communication with the flow rate controller to execute a test process including:
i) producing a stimulus according to a detection threshold test protocol for detecting a threshold of a cool mechanical stimulus administered to an ocular surface of the patient, and storing patient responses received at the user input device during execution of the detection threshold test protocol, the sequence controller determining the patient's detection threshold based on the stored patient responses for the detection threshold protocol;
ii) optionally producing a series of stimuli according to an adaptation test protocol for determining whether the patient adapts to a series of cooling mechanical stimuli administered to the ocular surface of the patient, and storing patient responses received at the user input device during execution of the adaptation test protocol, the controller determining whether the patient adapts to the series of cooling mechanical stimuli based on the stored patient responses for the adaptation test protocol; and
iii) generating data for classifying the patient as being predisposed to contact lens discomfort if the patient's detection threshold is below a predetermined cut-off associated with predisposition to contact lens discomfort and/or if the patient does not adapt to the series of cooling mechanical stimuli.

24. The analysis system of claim 23 , wherein the fluid is a gas, the cooling mechanical stimulus is a cool pneumatic stimulus, and the series of cooling mechanical stimuli is a series of pneumatic cooling stimuli.

Assignees

• Univ Indiana Res & Tech Corp

Inventors

• Situ ping
• Begley Carolyn
• Simpson Trefford L

Classifications

• A61B3/02 Primary

  Subjective types, i.e. testing apparatus requiring the active assistance of the patient · CPC title

• A61B3/00

  Apparatus for testing the eyes; Instruments for examining the eyes (eye inspection using ultrasonic, sonic or infrasonic waves A61B8/10) · CPC title

• A61B5/483

  by thermal stimulation · CPC title

• A61B3/0025

  characterised by electronic signal processing, e.g. eye models · CPC title

• A61B3/09 Primary

  for testing accommodation · CPC title