A study to compare prototype ophthalmic lenses and commercially available ophthalmic lenses -Part 2 0f 2..

Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: This is a randomized single‐masked (participant) crossover study design. Participants will attend for two study visits for each of the three lens designs (two prototypes and one control lens design). Each cross over period is separated by a one day wash out (1 night). • Following randomization, the participant will attend for Phase 2 visits. At Phase 2 – Visit 1(1.5hr) the randomized study lenses will be fitted by the optometrist using the study frame and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit. • The participant will return for the Phase 2 – Visit 2(1.5hr) after a minimum of two days of bilateral spectacle wear and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit (except only one measure for Choroidal thickness and axial length measures are required). Two days are defined where the study visits are separated by two nights. • Study Visit 2 exit; on completion of study visit 2 the Phase 0 lenses will be refitted to the study frame. • The lens power of each product will be based on the spherical equivalent of the best‐corrected subjective refraction found at baseline. After completing all six of the Phase 2 study visits the participant will exit the clinical trial. ‐ The two prototype ophthalmic lens design consist of a central zone with refractive power matched to the participant’s prescription, with a peripheral zone of different refractive power. The two prototypes differ in peripheral refractive power. ‐For the 2 days of bilateral spectacle wear a) participant need to wear the spectacles for all waking hours b) strategies for adherence included participant questionnaires that probe compliance, history taking investi CONDITION: Eye ‐ Diseases / disorders of the eye Myopia; ; Myopia PRIMARY OUTCOME: To compare the objective and subjective visual performance of participants wearing the prototype ophthalmic lenses to that observed with the commercially available lenses. The data analysis will be such that this is a composite and assessed using the Thomson visual acuity charts.; During Phase 2 Visit 1 below assessments will be done:; ‐ Presenting visual acuity; ‐Slit lamp biomicroscopy; ‐High contrast visual acuity in high and low illumination.; ‐Low contrast visual acuity in high illumination; ‐Contrast sensitivity in high illumination; ‐Glare test in low illumination; ‐Subjective Vision Ratings:1‐10 in high and low illumination ‐clarity of vision, ghosting, overall vision satisfaction; ‐Vision stability in high illumination; ‐Axial Length and Choroidal Thickness Measurements; Assessments for visit 2:; ‐Presenting VA; ‐Slit lamp biomicroscopy; ‐Subjective Vision Ratings:1‐10 in high and low illumination ‐clarity of vision, ghosting, overall vision satisfaction; ‐Vision stability in high illumination; ‐Axial Length and Choroidal Thickness Measurements.[In Phase 2 after 2 days of wear] SECONDARY OUTCOME: The measures will be composite. To compare the ocular physiological responses of axial length and choroidal thickness of the participants wearing the prototype ophthalmic lenses to that observed with the commercially available lenses. INCLUSION CRITERIA: Age in complete years ranging from 18 to 35 years, male or female. • Myopic spherical equivalent non‐cycloplegic subjective refractive error between ‐0.50D to ‐6.50D and cylinder up to and including ‐0.75DC • Vision of 6/7.5 (20/25) or better in each eye with or without correction • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. • Have ocular health findings considered to be “normal”. ; Secondary outcomes relate to the impact these lenses have on physiology of the eye, specifically axial length (measured by OLCR imaging and choroidal thickness (measured by OCT imaging). These biometric markers will be measured Pre and post lens wear and will inform any potential change in either of these components[In Phase 2, prior to use of the ophthalmic lenses, 1 hour following use and after 2 days of use.]
Epistemonikos ID: 7f741a4fd4496a6f9d5e1745e770f386922b0c18
First added on: Aug 25, 2024