Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
Brief 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.
Detailed description
This prospective, open-labeled, evaluation of clinical performance of the investigational EDOF and Toric EDOF (TEDOF) ICL will be conducted at a single site in the Philippines. Up to 45-50 subjects (90 eyes) who meet all eligibility criteria will be assigned to one of the following treatment arms, as determined by their preoperative refraction and the Investigator's medical judgement: * EDOF Toric ICL in both eyes, * EDOF Toric ICL in one eye and EDOF spherical ICL in fellow eye, * EDOF spherical ICL in both eyes (up to 20 subjects/40 eyes). Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.
Interventions
EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)
Sponsors
Staar Surgical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity | 1 month, 3 months and 6 months postoperatively | Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity |
| Change in refractive cylinder | 1 month, 3 months and 6 months postoperatively | Change from baseline in absolute magnitude of subjective refractive cylinder |
| Lens axis misalignment | 1 month, 3 months and 6 months postoperatively | Proportion of lenses with axis misalignment compared to operative day |
| Rotational stability | 1 day, 1, week, 1 month, 3 months and 6 months postoperatively | Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery |
| Compromise in visual acuity | 6 months postoperatively | Clinically significant compromise in visual acuity based on subject questionnaires |
Countries
Philippines
Outcome results
None listed