CompletedNot Applicable

Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

United States327 participantsStarted 2020-01-30

Plain-language summary

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Who can participate

Age range21 Years – 45 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: * Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers. * Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation. * Able and willing to return for scheduled follow-up examinations after surgery. * Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Insulin-dependent diabetes or diabetic retinopathy. * History of previous ocular surgery. * Cataract of any grade. * Monocular. * Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study. * Other protocol-specified exclusion criteria may apply.

What they're measuring

Number of Primary Eyes Requiring Peripheral Iridotomy (PI)

Timeframe: 6 Months

Endothelial Cell Density (ECD) Change in Primary Eyes.

Timeframe: 6 Months

Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Number of Ocular Adverse Events (AEs) in Primary Eyes.

Timeframe: 6 Months

Trial details

NCT IDNCT04283149

SponsorStaar Surgical Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-05

Results submitted2022-04-08

View on ClinicalTrials.gov More Myopia trials

Plain-language summary

Who can participate

Age range21 Years – 45 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

Number of Primary Eyes Requiring Peripheral Iridotomy (PI)

Timeframe: 6 Months

Endothelial Cell Density (ECD) Change in Primary Eyes.

Timeframe: 6 Months

Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.

Timeframe: 6 months

Number of Ocular Adverse Events (AEs) in Primary Eyes.

Timeframe: 6 Months