Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™
Study Details
Study Description
Brief Summary
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: wavefront-guided PRK with iDesign wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
Device: STAR S4 IR laser with iDesign
Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.
|
Outcome Measures
Primary Outcome Measures
- The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better [6 months]
At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.
Eligibility Criteria
Criteria
NOTE: Enrollment open only to military personnel
Inclusion Criteria:
-
Signed informed consent and HIPAA authorization.
-
Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
-
Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
-
Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
-
BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
-
Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
-
Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
-
Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
-
Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
-
Willing and capable of complying with follow-up examinations for the duration of the study.
Exclusion Criteria:
-
Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
-
Concurrent use of systemic (including inhaled) medications that may impair healing.
-
History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
-
Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
-
History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
-
Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
-
Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
-
If either eye does not meet all inclusion criteria
-
Desire to have monovision.
-
Participation in any other clinical study, with the exception of the fellow eye in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Naval Hospital Camp Pendleton | Camp Pendleton | California | United States | 92055 |
| 2 | Naval Medical Center | San Diego | California | United States | 92106 |
| 3 | Warfighter Eye Center Malcolm Grow Medical Clinics and Surgery Center | Andrews Air Force Base | Maryland | United States | 20762 |
| 4 | Naval Hospital Camp LeJeune | Camp Lejeune | North Carolina | United States | 28547 |
| 5 | William Beaumont Army Medical Center | El Paso | Texas | United States | 79920 |
| 6 | Joint Warfighter Refractive Surgery Center Wilford Hall Medical Center | Lackland Air Force Base | Texas | United States | 78236 |
| 7 | Naval Medical Center Portsmouth | Portsmouth | Virginia | United States | 23708 |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- STAR-115-MIPS
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes. |
| Arm/Group Title | PRK Correction With iDesign System and STAR S4 IR Laser |
|---|---|
| Arm/Group Description | Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
| Period Title: Overall Study | |
| STARTED | 167 |
| COMPLETED | 151 |
| NOT COMPLETED | 16 |
Baseline Characteristics
| Arm/Group Title | PRK Correction With iDesign System and STAR S4 IR Laser |
|---|---|
| Arm/Group Description | Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
| Overall Participants | 167 |
| Overall Eyes | 334 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
26.6
(5.41)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
53
31.7%
|
| Male |
114
68.3%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
3
1.8%
|
| Asian |
12
7.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
22
13.2%
|
| White |
110
65.9%
|
| More than one race |
20
12%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better |
|---|---|
| Description | At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis. |
| Arm/Group Title | PRK Correction With iDesign System and STAR S4 IR Laser |
|---|---|
| Arm/Group Description | Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
| Measure Participants | 162 |
| Measure Eyes | 324 |
| Count of Units [Eyes] |
324
|
Adverse Events
| Time Frame | 12 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | PRK Correction With iDesign System and STAR S4 IR Laser | |
| Arm/Group Description | Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser | |
All Cause Mortality |
||
| PRK Correction With iDesign System and STAR S4 IR Laser | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/167 (0%) | |
Serious Adverse Events |
||
| PRK Correction With iDesign System and STAR S4 IR Laser | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/167 (6%) | |
| Eye disorders | ||
| Retinal Detachment | 1/167 (0.6%) | 1 |
| Anterior Uveitis | 1/167 (0.6%) | 1 |
| Corneal Abrasions | 2/167 (1.2%) | 2 |
| Corneal Infiltrate | 2/167 (1.2%) | 2 |
| Corneal Haze | 2/167 (1.2%) | 3 |
| Corneal Erosion | 2/167 (1.2%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| PRK Correction With iDesign System and STAR S4 IR Laser | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/167 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.
Results Point of Contact
| Name/Title | Sanjeev Kasthurirangan Ph.D. |
|---|---|
| Organization | Johnson & Johnson Surgical Vision |
| Phone | +1 408-273-4081 |
| skasthur@its.jnj.com |
- STAR-115-MIPS