Testing two new methods to detect differences between contact lens materials
- Conditions
- Eye DiseasesDetermination of the repeatability of OTG-i Vision Suite, Landolt ring contrast sensitivity and In vivo de-wetting kinetics
- Registration Number
- ISRCTN84775121
- Lead Sponsor
- Ocular Technology Group-International (OTG-i)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
There are no requirements as to participant race or gender.
1. Age 18 to 35 years
2. Current daily disposable hydrogel or silicone hydrogel spherical contact lens wearer
3. Normal contact lens wearing characteristics as per Young modified questionnaire
4. Spectacle refraction:
4.1. Sphere: -6.00D to + 2.00D
4.2. Astigmatism: 0.00D to -0.75
5. Best corrected visual acuity of at least 20/25 in each eye
The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
The following are specific criteria that exclude a candidate from enrolment in this study:
1. Acute and subacute inflammation or infection of the anterior chamber of the eye
2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear
3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
4. Severe insufficiency of lacrimal secretion (dry eyes)
5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema)
6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
7. Any active corneal infection (bacterial, fungal, protozoal or viral)
8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
11. History of corneal refractive surgery
12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Post hoc analysis of tearscope digital video recording using scale percentage exposure per second, performed during visit 2 and visit 3<br>2. Timed letter contrast sensitivity using OTGi vision suite, the scale is in Log of contrast percentage, performed during visit 2 and visit 3
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures