Myopia, Myopic Astigmatism
Conditions
Keywords
nearsightedness, phakic IOL, toric ICL, ICL, TICL, EVO, astigmatism
Brief summary
The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
Detailed description
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.
Interventions
DEVICEEVO ICL
The EVO 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.
Sponsors
Staar Surgical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to high myopia correctable with available EVO ICL powers. * Moderate to high myopic with astigmatism correctable with available EVO ICL powers. * Stable refractive history within 0.50 D cylinder for 1 year prior to implantation. * Stable refractive history within 0.50 D for spherical equivalent 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
* Ocular hypertension or glaucoma. * Insulin dependent diabetes or diabetic retinopathy. * History of previous ocular surgery. * Monocular. * Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg | 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. |
| Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg | 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. |
| Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG | 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. |
Countries
United States
Contacts
STUDY_DIRECTORJoanne Egamino, PhD
Staar Surgical Company
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| EVO ICL Enrolled patients who underwent surgery with an ICL lens in at least one eye. | 205 |
| Total | 205 |
Baseline characteristics
| Characteristic | EVO ICL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 205 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 176 Participants |
| Region of Enrollment United States | 205 Participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 205 |
| other Total, other adverse events | 45 / 408 |
| serious Total, serious adverse events | 2 / 408 |
Outcome results
Primary
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg
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.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg | 15 Eyes |
Primary
Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG
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.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG | 4 Eyes |
Secondary
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg
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.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg | 16 Eyes |
Secondary
Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG
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.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG | 6 Eyes |
Other Pre-specified
Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | 0 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes
Time frame: Day 10-18 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | 6 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.
Time frame: Day 1 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | 0 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes
Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes.
Time frame: Day 5-9 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | 1 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
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.
Time frame: Day 5-9 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | 43 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
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.
Time frame: 1-6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | 42 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
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.
Time frame: Day 1 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | 43 Eyes |
Other Pre-specified
Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD
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.
Time frame: Day 10-18 postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Primary Eyes | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | 43 Eyes |