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

• Sponsor: Staar Surgical Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04283149
• Collaborator: (none)
• Enrollment: 327
• Locations: 14
• Arms: 2
• Anticipated Duration (Months): 41
• Patients Per Site: 23.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Myopic Astigmatism	Device: EVO/EVO+ Visian ICL	N/A

Detailed Description

This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 327 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
• Actual Study Start Date: Jan 30, 2020
• Actual Primary Completion Date: Apr 5, 2021
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary Eyes First implanted eyes of enrolled participants	Device: 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.
Experimental: Fellow Eyes Second implanted eyes of enrolled participants	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Primary Eyes Requiring Peripheral Iridotomy (PI) [6 Months]

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

2. Endothelial Cell Density (ECD) Change in Primary Eyes. [6 Months]

   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.

3. Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes. [6 months]

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

4. Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. [6 months]

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

5. Number of Ocular Adverse Events (AEs) in Primary Eyes. [6 Months]

Secondary Outcome Measures

1. Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI) [6 Months]

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

2. Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. [6 Months]

   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.

3. Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes. [6 months]

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

4. Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes. [6 months]

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

5. Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes [6 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnett Dulaney Perkins	Phoenix	Arizona	United States	85106
2	Aloha Laser Vision, LLC	Honolulu	Hawaii	United States	96814
3	Price Vision Group,	Indianapolis	Indiana	United States	46260
4	Durrie Vision	Overland Park	Kansas	United States	66210
5	Solomon Eye Physicians and Surgeons/Bowie Vision Institute	Bowie	Maryland	United States	20716
6	Brinton Vision	Saint Louis	Missouri	United States	63141
7	Kugler Vision, PC	Omaha	Nebraska	United States	68118
8	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
9	Kremer Eye Center	King Of Prussia	Pennsylvania	United States	19406
10	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108
11	Key-Whitman Eye Center	Dallas	Texas	United States	75243
12	Parkhurst NuVision	San Antonio	Texas	United States	78229
13	Hoopes Vision/Hoopes, Durrie, Rivera Research	Draper	Utah	United States	84020
14	The Eye Institute of Utah	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Staar Surgical Company

Investigators

• Study Director: Joanne Egamino, PhD, VP, Global Clinical Affairs

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2020

More Information

Publications

None provided.

• Responsible Party: Staar Surgical Company
• ClinicalTrials.gov Identifier: NCT04283149
• Other Study ID Numbers: CP19-01
• First Posted: Feb 25, 2020
• Last Update Posted: Jul 27, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Staar Surgical Company: Nearsightedness; Phakic intraocular lens (IOL); ICL; Toric ICL; EVO; EVO+; Visian
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Primary Eyes	Fellow Eyes
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	327	327
Postoperative Month 6	321	321
COMPLETED	0	0
NOT COMPLETED	327	327

Baseline Characteristics

Arm/Group Title	EVO ICL
Arm/Group Description	Enrolled patients who underwent surgery with an investigational lens in at least one eye
Overall Participants	327
Overall Eyes	629
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	327 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	213 65.1%
Male	114 34.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	34 10.4%
Not Hispanic or Latino	293 89.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%
Asian	38 11.6%
Native Hawaiian or Other Pacific Islander	3 0.9%
Black or African American	11 3.4%
White	274 83.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	327 100%
Preoperative Manifest Refraction Spherical Equivalent (Diopters) [Mean (Standard Deviation) ]
Primary Eyes	-7.63 (2.80)
Fellow Eyes	-7.61 (2.72)

Outcome Measures

1. Primary Outcome

Title	Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
Description	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary Eyes
Arm/Group Description	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.
Measure Participants	327
Measure Eyes	327
Number [eyes]	0

2. Primary Outcome

Title	Endothelial Cell Density (ECD) Change in Primary Eyes.
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary Eyes
Arm/Group Description	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.
Measure Participants	321
Measure Eyes	321
Mean (95% Confidence Interval) [percentage change]	-2.4

3. Primary Outcome

Title	Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Description	Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary Eyes
Arm/Group Description	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.
Measure Participants	321
Measure Eyes	321
Number (95% Confidence Interval) [eyes]	0

4. Primary Outcome

Title	Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Description	Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary Eyes
Arm/Group Description	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.
Measure Participants	321
Measure Eyes	321
Number (95% Confidence Interval) [eyes]	0

5. Primary Outcome

Title	Number of Ocular Adverse Events (AEs) in Primary Eyes.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary Eyes
Arm/Group Description	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.
Measure Participants	327
Measure Eyes	327
Number [events]	108

6. Secondary Outcome

Title	Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
Description	Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary and Fellow Eyes
Arm/Group Description	Primary and fellow implanted eyes 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.
Measure Participants	327
Measure Eyes	629
Number [eyes]	0

7. Secondary Outcome

Title	Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary and Fellow Eyes
Arm/Group Description	Primary and fellow implanted eyes 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.
Measure Participants	321
Measure Eyes	619
Mean (95% Confidence Interval) [percentage change]	-2.26

8. Secondary Outcome

Title	Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
Description	Number of eyes with ECD <1000 cell/mm² at month 6 in primary and fellow eyes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary and Fellow Eyes
Arm/Group Description	Primary and fellow implanted eyes 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.
Measure Participants	321
Measure Eyes	619
Number (95% Confidence Interval) [Eyes]	0

9. Secondary Outcome

Title	Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
Description	Number of eyes with ECD <1500 cell/mm² at month 6 in primary and fellow eyes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Primary and Fellow Eyes
Arm/Group Description	Primary and fellow implanted eyes 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.
Measure Participants	321
Measure Eyes	619
Number (95% Confidence Interval) [eyes]	0

10. Secondary Outcome

Title	Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary and Fellow Eyes
Arm/Group Description	Primary and fellow implanted eyes 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.
Measure Participants	327
Measure Eyes	629
Number [events]	203

Adverse Events

Time Frame	6 months.
Adverse Event Reporting Description	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.
Arm/Group Title	Primary Eyes		Fellow Eyes		Non-Ocular Serious Adverse Events
Arm/Group Description	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.		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.		Participants who experienced a non-ocular Serious Adverse Event.
All Cause Mortality
	Primary Eyes		Fellow Eyes		Non-Ocular Serious Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/327 (0%)		0/302 (0%)		0/327 (0%)
Serious Adverse Events
	Primary Eyes		Fellow Eyes		Non-Ocular Serious Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/327 (3.1%)		6/302 (2%)		2/327 (0.6%)
Eye disorders
Glare/Halo	1/327 (0.3%)	1	0/302 (0%)	0	0/327 (0%)	0
Narrow anterior chamber angle	2/327 (0.6%)	3	0/302 (0%)	0	0/327 (0%)	0
Retinal detachment	1/327 (0.3%)	1	2/302 (0.7%)	2	0/327 (0%)	0
Retinal tear	0/327 (0%)	0	1/302 (0.3%)	2	0/327 (0%)	0
Intraocular lens exchange	2/327 (0.6%)	2	0/302 (0%)	0	0/327 (0%)	0
Intraocular lens removal	1/327 (0.3%)	1	0/302 (0%)	0	0/327 (0%)	0
Intraocular lens repositioning	2/327 (0.6%)	2	1/302 (0.3%)	1	0/327 (0%)	0
Retinal Surgery	1/327 (0.3%)	2	2/302 (0.7%)	5	0/327 (0%)	0
Nervous system disorders
Amnesia	0/327 (0%)	0	0/302 (0%)	0	1/327 (0.3%)	1
Vascular disorders
Cerebral Infarction	0/327 (0%)	0	0/302 (0%)	0	1/327 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Primary Eyes		Fellow Eyes		Non-Ocular Serious Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/327 (25.1%)		65/302 (21.5%)		0/0 (NaN)
Eye disorders
Intraocular pressure increased	75/327 (22.9%)	77	61/302 (20.2%)	66	0/0 (NaN)	0
Anterior chamber cell/flare	7/327 (2.1%)	7	4/302 (1.3%)	4	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.