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Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wavefront-guided PRK with iDesign | Experimental | wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR S4 IR laser with iDesign | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better | At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly. | 6 months |
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NOTE: Enrollment open only to military personnel
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36730946 | Derived | Hofmeister EM, Cason JB, Murdoch DM, Yau IW, Wang Y, Parizadeh DD, Janakiraman DP, Kasthurirangan S. Wavefront-guided PRK treatment of myopia using a refractive aberrometer. J Cataract Refract Surg. 2023 Mar 1;49(3):292-298. doi: 10.1097/j.jcrs.0000000000001083. |
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235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRK Correction With iDesign System and STAR S4 IR Laser | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRK Correction With iDesign System and STAR S4 IR Laser | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better | At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly. | Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis. | Posted | Count of Units | Eyes | 6 months | Eyes | Eyes |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRK Correction With iDesign System and STAR S4 IR Laser | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjeev Kasthurirangan Ph.D. | Johnson & Johnson Surgical Vision | +1 408-273-4081 | skasthur@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2015 | Jul 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2015 | Jul 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Eyes |
|
| Years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Participants |
|
| Eyes |
|
|
| 0 |
| 167 |
| 10 |
| 167 |
| 0 |
| 167 |
| Anterior Uveitis | Eye disorders | Systematic Assessment |
|
| Corneal Abrasions | Eye disorders | Systematic Assessment |
|
| Corneal Infiltrate | Eye disorders | Systematic Assessment |
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| Corneal Haze | Eye disorders | Systematic Assessment |
|
| Corneal Erosion | Eye disorders | Systematic Assessment |
|
The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.