Stable Myopic Refractive Error, With or Without Astigmatism Clinical Trial
Official title:
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
| Verified date | December 2021 |
| Source | Abbott Medical Optics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
| Status | Completed |
| Enrollment | 167 |
| Est. completion date | July 27, 2018 |
| Est. primary completion date | July 27, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Warfighter Eye Center Malcolm Grow Medical Clinics and Surgery Center | Andrews Air Force Base | Maryland |
| United States | Naval Hospital Camp LeJeune | Camp Lejeune | North Carolina |
| United States | Naval Hospital Camp Pendleton | Camp Pendleton | California |
| United States | William Beaumont Army Medical Center | El Paso | Texas |
| United States | Joint Warfighter Refractive Surgery Center Wilford Hall Medical Center | Lackland Air Force Base | Texas |
| United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
| United States | Naval Medical Center | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Optics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 6 months |