Influences of Viscosity of Lubricating Eye Drops on Orthokeratology Treatment Outcomes
Influences of Viscosity of Lubricating Eye Drops on Treatment Outcomes in Ortho-K contact lens wearers.
Ms Kuan-Li Lily Ho
13 participants
Jun 3, 2019
Interventional
Conditions
Summary
The aim of this study is to determine whether the thickness of lubricating eye drops for the front surface of the eye influences orthokeratology (OK) contact lens treatment outcomes. The primary outcomes to be measured are anterior eye health and comfort; the secondary outcomes of vision (eye prescription and how well an OK wearer sees) will also be explored with non-contact instruments. The participant, who is an existing OK lenses wearer, will be required to use their own lenses along with two lubricating eye drops that will be given to them by the researchers. These drops will be used once before inserting their lenses at night and once again before removing them. The participants will be required to visit the research clinic and researchers (UNSW Optometry Clinic, Kensington, NSW, Australia 2052) once a week for a total of 4 visits throughout the study. After the 2nd visit, the participants will undergo a wash-out period where they will be instructed to not use the provided lubricating eye drops. In this period, the participants have the opportunity to schedule their 3rd and 4th visit to their earliest convenience. Therefore, the participants can finish the study as quick as 1 month after applying.
Eligibility
Inclusion Criteria5
- At least 18 years of age
- Have worn the same pair of orthokeratology lenses regularly for at least 1 month
- Good understanding of and ability to communicate using the English language
- Willing to comply with use of ocular lubricants involved and visit schedule
- No known allergy to ocular lubricants
Exclusion Criteria4
- Currently under the treatment of any eye disease (whether that be anterior or posterior eye involvement) except refractive error corrections
- Use of oral or topical medications that may alter eye findings
- Any previous ocular injuries, eye conditions or eye surgeries
- Has worn soft contact lenses in the past week
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Interventions
The study aims to determine whether the thickness (viscosity) of lubricating eye drops influences orthokeratology treatment outcomes. The primary outcomes to be measured are anterior eye health and comfort; secondary outcomes such as change in eye prescription and uncorrected vision will also be explored. Eye drops used will be the thinner carboxymethyl cellulose 0.25% (Theratears) (Advanced Vision Research) and thicker carboxymethyl cellulose 1% (Theratears Liquid Gel) (Advanced Vision Research) or carboxymethyl cellulose 1% (Lumecare Singles Carmellose) (Contact Lens Australia). The choice for the thicker lubricant will solely be based on availability when the study commences but all participants will receive the same thick lubricant. Participants will be given the thicker lubricating eye drop to be placed, at random, either in the left eye or right eye. They will be instructed to place 1 drop before inserting their OK lenses at night and 1 drop before removing the OK lenses in the following morning which will be repeated for 1 week whilst filling in a follow-up questionnaire at home. The thinner lubricating eye drop will be given to the fellow eye and the same instructions are given. The eye drops are to be applied topically and participants will be using their own prescribed OK lenses. After 1 week, they will revisit the researchers for Visit 2 and commence the 1 week washout period. After this period, where the participants are told to not use any of the given eye drops, they will be given a new set of lubricating eye drops which swaps the eye drops over to the other eye, completing the cross-over study design. In order to ensure the participants completes and follows the instructions set out by the research team, the participants will be required to fill out a follow-up questionnaire after the removal of their OK lenses each day. This questionnaire contains questions such as time of insertion/removal, vision and subjective comfort which will be collected after each visit. Additional procedures to ensure the protocol is followed is by re-explaining the instructions and to collect any remaining lubricants after each visit.
Locations(1)
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ACTRN12619000773134