CompletedNot Applicable

A Clinical Evaluation of a Phakic Intraocular Lens

Philippines47 participantsStarted 2022-08-22

Plain-language summary

The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism.

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Require a spherical lens power from -18.00 Diopters to +3.00 Diopters in both eyes or (in case of EDOF Toric) additional cylindrical lens power between +1.0 to +3.0 Diopters of Cylinder. * Stable refractive history (+/-0.50 Diopters) as determined by manifest spherical equivalent. * Requires +1.00 Diopters to +2.50 Diopters reading add in both eyes. * Minimum distance corrected near visual acuity of 20/40 or worse in both eyes. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * History of previous ocular surgery. * Progressive sight threatening disease. * Low/abnormal endothelial cell density. * Monocular. * Serious acute non-ophthalmic disease. * Pregnant or nursing women, or those who plan to become pregnant over the course of the study. * Other protocol-specified exclusion criteria may apply.

What they're measuring

Change in visual acuity

Timeframe: 1 month, 3 months and 6 months postoperatively

Change in refractive cylinder

Timeframe: 1 month, 3 months and 6 months postoperatively

Lens axis misalignment

Timeframe: 1 month, 3 months and 6 months postoperatively

Rotational stability

Timeframe: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively

Compromise in visual acuity

Timeframe: 6 months postoperatively

Trial details

NCT IDNCT07291739

SponsorStaar Surgical Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-18

View on ClinicalTrials.gov More Myopia trials

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in visual acuity

Timeframe: 1 month, 3 months and 6 months postoperatively

Change in refractive cylinder

Timeframe: 1 month, 3 months and 6 months postoperatively

Lens axis misalignment

Timeframe: 1 month, 3 months and 6 months postoperatively

Rotational stability

Timeframe: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively

Compromise in visual acuity

Timeframe: 6 months postoperatively