Trial Outcomes & Findings for Post-Market Evaluation of the EVO ICL (NCT NCT05538754)

NCT ID: NCT05538754

Last Updated: 2025-03-07

Results Overview

The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 205 participants
• Primary outcome timeframe: 1-6 hours postoperatively
• Results posted on: 2025-03-07

Participant Flow

205 subjects were enrolled and treated at 8 clinical sites in the United States. The first enrolled subject underwent surgery in the primary eye on 05 Oct 2022 and the last eye was implanted on 21 Sep 2023.

Unit of analysis: Eyes

Participant milestones

Measure	Primary Eyes First implanted eyes of enrolled subjects. EVO/EVO+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 subjects. EVO/EVO+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	205 205	205 203
Overall Study COMPLETED	205 205	205 203
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Market Evaluation of the EVO ICL

Baseline characteristics by cohort

Measure	EVO ICL n=205 Participants Enrolled patients who underwent surgery with an ICL lens in at least one eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	176 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	205 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-6 hours postoperatively

The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Outcome measures

Measure	Primary Eyes n=205 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg	15 Eyes

PRIMARY outcome

Timeframe: 1-6 hours postoperatively

The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Outcome measures

Measure	Primary Eyes n=205 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG	4 Eyes

SECONDARY outcome

Timeframe: 1-6 hours postoperatively

The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Outcome measures

Measure	Primary Eyes n=203 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg	16 Eyes

SECONDARY outcome

Timeframe: 1-6 hours postoperatively

The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea.

Outcome measures

Measure	Primary Eyes n=203 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG	6 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-6 hours postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	42 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-6 hours postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	0 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	43 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	0 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 5-9 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	43 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 5-9 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	1 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 10-18 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye.

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD	43 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 10-18 postoperatively

Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes

Outcome measures

Measure	Primary Eyes n=408 Eyes First implanted eyes of enrolled patients. EVO/EVO+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.
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes	6 Eyes

Adverse Events

All Treated Eyes

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Treated Eyes n=408 participants at risk EVO/EVO+ ICL: the investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior chamber of the human crystalline lens.
Eye disorders Incorrect EVO ICL Implantation	0.25% 1/408 • Number of events 1 • Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks) 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	0.25% 1/408 • Number of events 1 • Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks) 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 Cilium	0.25% 1/408 • Number of events 1 • Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks) 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 Surgery to Remove Intraocular Cilium	0.25% 1/408 • Number of events 1 • Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks) 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

All Treated Eyes n=408 participants at risk EVO/EVO+ ICL: the investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior chamber of the human crystalline lens.

Eye disorders Intraocular Pressure Increased

11.0% 45/408 • Number of events 49 • Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks) 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 designee is completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreements 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 the Sponsor or designee for comment.
• Publication restrictions are in place

Restriction type: OTHER