Pilot Early-Stage Testing and Assessment of Ophthalmic Lens Prototypes (The PESTA Study)

Not Applicable

• Conditions: Refractive error that requires optical correction; Eye - Normal eye development and function

• Registration Number: ACTRN12622000709741
• Lead Sponsor: Brien holden vision institute limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-17
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be 18years and above.
- Willing to comply with the wearing of the study lenses and the clinical trial visit schedule as directed by the Investigator.
- Have ocular health findings considered to be normal”
- Spherical prescription range of +6.00D to -6.00DS inclusive and astigmatism <-2.00DC.Reading add power of <+3.00D
- Vision of 6/7.5 (20/25) or better in each eye with or without correction.
- Spectacle and/or contact lens wearers or participants not requiring any optical correction.

Exclusion Criteria

- Have strabismus and/or amblyopia.
- Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves’ disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren’s syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Previous corneal refractive surgery.
- Known allergy or intolerance to ingredients in any of the clinical trial products.
- Pregnancy*.
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.*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified