Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2022-08-22
2024-10-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EDOF ICL
Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction
Implantable Collamer Lens (ICL)
EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)
Interventions
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Implantable Collamer Lens (ICL)
EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
60 Years
ALL
Yes
Sponsors
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Staar Surgical Company
INDUSTRY
Responsible Party
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Locations
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Asian Eye Institute
Makati City, , Philippines
Countries
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Other Identifiers
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CP18-01
Identifier Type: -
Identifier Source: org_study_id