Trial Outcomes & Findings for Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL) (NCT NCT04283149)

NCT ID: NCT04283149

Last Updated: 2025-03-07

Results Overview

Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 327 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2025-03-07

Participant Flow

327 subjects were enrolled and treated at 14 clinical sites in the US. The first enrolled subject underwent surgery in the primary eye in January 2020 and the last eye was implanted in December 2020.

Unit of analysis: eyes

Participant milestones

Measure	Primary Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Fellow Eyes Second implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Overall Study STARTED	327 327	327 302
Overall Study Postoperative Month 6	321 321	321 298
Overall Study COMPLETED	0 0	0 0
Overall Study NOT COMPLETED	327 327	327 302

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

327 participants were enrolled with analysis presented for primary eye (n=327) and fellow eye (n=302)

Baseline characteristics by cohort

Measure	EVO ICL n=629 Eyes Enrolled patients who underwent surgery with an investigational lens in at least one eye
Age, Categorical <=18 years	0 Participants n=327 Participants
Age, Categorical Between 18 and 65 years	327 Participants n=327 Participants
Age, Categorical >=65 years	0 Participants n=327 Participants
Sex: Female, Male Female	213 Participants n=327 Participants
Sex: Female, Male Male	114 Participants n=327 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=327 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	293 Participants n=327 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=327 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=327 Participants
Race (NIH/OMB) Asian	38 Participants n=327 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=327 Participants
Race (NIH/OMB) Black or African American	11 Participants n=327 Participants
Race (NIH/OMB) White	274 Participants n=327 Participants
Race (NIH/OMB) More than one race	0 Participants n=327 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=327 Participants
Region of Enrollment United States	327 participants n=327 Participants
Preoperative Manifest Refraction Spherical Equivalent Primary Eyes	-7.63 Diopters STANDARD_DEVIATION 2.80 • n=327 Eyes • 327 participants were enrolled with analysis presented for primary eye (n=327) and fellow eye (n=302)
Preoperative Manifest Refraction Spherical Equivalent Fellow Eyes	-7.61 Diopters STANDARD_DEVIATION 2.72 • n=302 Eyes • 327 participants were enrolled with analysis presented for primary eye (n=327) and fellow eye (n=302)

PRIMARY outcome

Timeframe: 6 Months

Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.

Outcome measures

Measure	Primary Eyes n=327 Participants First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)	0 eyes

PRIMARY outcome

Timeframe: 6 Months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density.

Outcome measures

Measure	Primary Eyes n=321 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) Change in Primary Eyes.	-2.4 percentage change Interval -2.86 to -1.92

PRIMARY outcome

Timeframe: 6 months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.

Outcome measures

Measure	Primary Eyes n=321 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.	0 eyes Interval 0.0 to 1.14

PRIMARY outcome

Timeframe: 6 months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.

Outcome measures

Measure	Primary Eyes n=321 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.	0 eyes Interval 0.0 to 1.14

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Measure	Primary Eyes n=327 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Number of Ocular Adverse Events (AEs) in Primary Eyes.	108 events

SECONDARY outcome

Timeframe: 6 Months

Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.

Outcome measures

Measure	Primary Eyes n=629 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)	0 eyes

SECONDARY outcome

Timeframe: 6 Months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density.

Outcome measures

Measure	Primary Eyes n=619 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.	-2.26 percentage change Interval -2.57 to -1.94

SECONDARY outcome

Timeframe: 6 months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.

Outcome measures

Measure	Primary Eyes n=619 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.	0 Eyes Interval 0.0 to 0.59

SECONDARY outcome

Timeframe: 6 months

Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.

Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.

Outcome measures

Measure	Primary Eyes n=619 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.	0 eyes Interval 0.0 to 0.59

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Measure	Primary Eyes n=629 Eyes First implanted eyes of enrolled participants EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes	203 events

Adverse Events

Primary Eyes

Serious events: 10 serious events

Other events: 82 other events

Deaths: 0 deaths

Fellow Eyes

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

Non-Ocular Serious Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Primary Eyes n=327 participants at risk EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Fellow Eyes n=302 participants at risk EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Non-Ocular Serious Adverse Events n=327 participants at risk Participants who experienced a non-ocular Serious Adverse Event.
Eye disorders Glare/Halo	0.31% 1/327 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Narrow anterior chamber angle	0.61% 2/327 • Number of events 3 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Retinal detachment	0.31% 1/327 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.66% 2/302 • Number of events 2 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Retinal tear	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.33% 1/302 • Number of events 2 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Intraocular lens exchange	0.61% 2/327 • Number of events 2 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Intraocular lens removal	0.31% 1/327 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Intraocular lens repositioning	0.61% 2/327 • Number of events 2 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.33% 1/302 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Retinal Surgery	0.31% 1/327 • Number of events 2 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.66% 2/302 • Number of events 5 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Nervous system disorders Amnesia	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.31% 1/327 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Vascular disorders Cerebral Infarction	0.00% 0/327 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.00% 0/302 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	0.31% 1/327 • Number of events 1 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.

Other adverse events

Measure	Primary Eyes n=327 participants at risk EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Fellow Eyes n=302 participants at risk EVO/EVO+ Visian ICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Non-Ocular Serious Adverse Events n=327 participants at risk Participants who experienced a non-ocular Serious Adverse Event.
Eye disorders Intraocular pressure increased	22.9% 75/327 • Number of events 77 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	20.2% 61/302 • Number of events 66 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	— 0/0 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
Eye disorders Anterior chamber cell/flare	2.1% 7/327 • Number of events 7 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	1.3% 4/302 • Number of events 4 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.	— 0/0 • 6 months. Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.

Additional Information

Joanne Egamino

STAAR Surgical

Phone: 626-303-7902

Email: jegamino@staar.com

Results disclosure agreements

• Principal investigator is a sponsor employee All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to Sponsor or designee for comment.
• Publication restrictions are in place

Restriction type: OTHER