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Impact of binocular vision disorders on contact lens dissatisfaction in non-presbyopic adult contact lens wearers.

A prospective study in a population of myopic non-presbyopic adult contact lens wearers to determine a suitable measure of contact lens dissatisfaction and to determine the extent to which binocular vision disorders contribute to contact lens dissatisfaction.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000175370
Enrollment
76
Registered
2017-02-02
Start date
2017-04-13
Completion date
2018-07-24
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Contact lens dissatisfaction is a major problem for contact lens wearers. Most research efforts have concentrated on contact lens discomfort as a source of contact lens dissatisfaction, but binocular vision disorders among contact lens wearers has not been researched as a potential source of contact lens dissatisfaction. This study aims to identify a questionnaire which measures dissatisfaction due to symptoms from binocular-vision disorders and discomfort in myopic non-presbyopic adult contact lens wearers and to determine the extent to which binocular-vision disorders contribute to contact lens dissatisfaction.

Interventions

This will be a prospective study in a population of myopic non-presbyopic adult contact lens wearers. On successful enrollment, participants will complete two validated questionnaire comprising the Convergence Insufficiency Syndrome Survey (CISS) and the Contact Lens Dry Eye- Questionnaire-8 (CLDEQ-8). The CISS assesses symptoms arising from binocular vision disorders and the CLDEQ-8 assessed symptoms arising from contact lens dryness. Each participant will complete questionnaires according to a

This will be a prospective study in a population of myopic non-presbyopic adult contact lens wearers. On successful enrollment, participants will complete two validated questionnaire comprising the Convergence Insufficiency Syndrome Survey (CISS) and the Contact Lens Dry Eye- Questionnaire-8 (CLDEQ-8). The CISS assesses symptoms arising from binocular vision disorders and the CLDEQ-8 assessed symptoms arising from contact lens dryness. Each participant will complete questionnaires according to a pre-determined randomization plan to minimize potential bias arising from completing questionnaires in the same order. Participants will be given the second questionnaire only after completing and returning the first questionnaire. A standard, optometric binocular vision assessment will be performed and participants will be classified as either having a binocular vision disorder or not having a binocular vision disorder. Participants will be sent a set of three contact lens dissatisfaction questionnaires after completing the standard, optometric binocular vision assessment. These questionnaires comprise the Contact Lens Impact on Quality-of-life (CLIQ), the Ocular Surface Disease Index (OSDI) and the Ranked Symptom Survey (RSS). The CLIQ is a validated quality-of-life questionnaire aimed specifically at non-presbyopic contact lens wearers. The OSDI is a validated questionnaire comprising three subscales assessing assess vision-related function, ocular symptoms and environmental triggers. The RSS comprises three subscales assessing discomfort, vision dissatisfaction and lens handling dissatisfaction. On completion and return of the questionnaires, a second set of the same questionnaires will be sent within 5-7 days. Participants will complete and return the second set of questionnaires. Each participant will complete each set of three questionnaires according to a pre-determined randomization plan to minimize potential bias arising from completing questionnaires in the same order.

Sponsors

Brien Holden Vision Institute
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Participants must: *Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. *Be between 18-40 years old, male or female. *Have less than or equal to 1.00 D cylindrical power in either eye. *Achieve at least 0.20 LogMAR (6/9.5) or better in each eye with no more than a one-line difference (0.10 LogMAR) between eyes with current contact lenses. *Willing to comply with the clinical trial as directed by the Investigator. *Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. *Be an experienced spherical contact lens wearer with current contact lens prescription at least one week old.

Exclusion criteria

Participants must not have: *Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. *Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. *Use of or a need for concurrent category S3 and above ocular medication at enrolment. *Eye surgery within 12 weeks immediately prior to enrolment for this trial. *Previous corneal refractive surgery. *Previous surgery on the extra ocular muscles. *Contraindications to contact lens wear. *Currently enrolled in another clinical trial. *Pregnancy. Formal testing of pregnancy is not required. A participant’s verbal report is sufficient. The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026