Clinical Performance of a Phakic Intraocular Lens (IOL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499821|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Device: EDOF ICL||Not Applicable|
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.
Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery.
The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance.
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Device: Open label, all subjects receive same treatment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens|
|Actual Study Start Date :||March 20, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
Experimental: Study population
EDOF ICL implanted into both eyes of eligible subjects.
Device: EDOF ICL
The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Other Name: EVO+ Visian ICL with Aspheric (EDOF) Optic
- Uncorrected Near Visual Acuity (UCNVA) [ Time Frame: 6 months ]monocular UCNVA of Snellen equivalent 20/40 or better
- UCNVA [ Time Frame: 1 and 3 months ]monocular UCNVA of Snellen equivalent 20/40 or better
- Uncorrected Intermediate Visual Acuity (UCIVA) [ Time Frame: 1,3 and 6 months ]Change from baseline in monocular UCIVA
- UCNVA change from baseline [ Time Frame: 1,3 and 6 months ]Change from baseline in monocular UCNVA
- Distance Corrected Intermediate Visual Acuity (DCIVA) [ Time Frame: 1,3 and 6 months ]Change from baseline in monocular DCIVA
- Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 1,3 and 6 months ]Change from baseline in monocular DCNVA
- Binocular UCNVA [ Time Frame: 1,3 and 6 months ]Change from baseline in binocular UCNVA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499821
|Antwerp, Belgium, B-2610|
|Instituto Oftalmológico Fernández-Vega|
|Oviedo, Asturias, Spain, 33012|
|Qvision-Hospital Vithas Virgen del Mar|
|Almería, Spain, 04120|
|IMO Instituto de Microcirugía Ocular|
|Barcelona, Spain, 08035|
|Innova Ocular Begitek|
|San Sebastián, Spain, 20012|
|Clínica Oftalmológica Gasteiz|
|Vitoria-Gasteiz, Spain, 01005|
|Study Director:||Jon K Hayashida, OD, FAAO||Staar Surgical Company|