The Acceptability of an Alternative Contact Lens Treatment for People with Keratoconus.

Investigation of the Satisfaction and Acceptability of the SynergEyes (trademark) Hybrid Contact Lens for Keratoconic Corneas in New Zealand.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000206022

Enrollment

Registered

2010-03-11

Start date

2010-05-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study will investigate satisfaction with SynergEyes (trademark) hybrid contact lenses and gather information to design and power a larger study to investigate clinical effects. We will measure and assess the ease of fit, comfort and vision, as well as monitoring changes in eye health throughout the project. This will give an indication of the success of fitting SynergEyes (trademark) hybrid lenses in comparison to RGPs. We will also monitor any adverse side effects from SynergEyes (trademark) hybrid lenses.

Interventions

Third generation hybrid contact lens. They are to be worn by study participants full time, for at least 8 hours during the daytime and removed before sleeping, for a total of 6 weeks.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

17 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1) All subjects over 16 years of age, previously diagnosed with keratoconus in both eyes. 2) Keratoconic subjects who are prepared to try SynergEyes (trademark) hybrid contact lenses as a form of visual correction. 3) Keratoconic subjects who have worn RGP contact lenses for at least 8 hours a day for at least 6 weeks before commencing this study.

Exclusion criteria

1) Subjects with corneal dystrophies/disease other than keratoconus 2) Normal subjects who do not have keratoconus

Outcome results