An interventional study of Implantable Collamer Lens (ICL) in Myopia, Hyperopia and Astigmatism, sponsored by Staar Surgical Company. Completed at 1 site in Philippines. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Staar Surgical Company · Not applicable, Interventional, and Treatment
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.
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:
Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 47 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Staar Surgical Company is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction
Device: Implantable Collamer Lens (ICL)
EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)
Change in visual acuity
Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity
Time frame: 1 month, 3 months and 6 months postoperatively
Change in refractive cylinder
Change from baseline in absolute magnitude of subjective refractive cylinder
Time frame: 1 month, 3 months and 6 months postoperatively
Lens axis misalignment
Proportion of lenses with axis misalignment compared to operative day
Time frame: 1 month, 3 months and 6 months postoperatively
Rotational stability
Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery
Time frame: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively
Compromise in visual acuity
Clinically significant compromise in visual acuity based on subject questionnaires
Time frame: 6 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Oct 2024, 25 months.
Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 25 months is above that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Staar Surgical Company