Refractive Error Correction
Conditions
Brief summary
This is a prospective non-randomized patient controlled single center study which is designed to evaluate the clinical outcomes of the treatment of an implanted intraocular lens using a low-energy femtosecond laser for refractive correction.
Detailed description
The purpose of this research study is to evaluate the safety and efficacy of the treatment of an implanted intraocular lens with a device. The device employs a generic femtosecond laser used in numerous other ophthalmic procedures. The device uses low levels of energy from the femtosecond laser to correct spherical, cylindrical and sphero-cylindrical refractive error existing in an implanted intraocular lens. The refractive correction is effected through the treatment, which is employed at least 30 days after cataract surgery.
Interventions
OTHERDevice
The Perfector is used in the procedure. The device is attached to the patient by the use of a patient attachment. The patient attachment attaches to the sclera of the eye using vacuum pressure.
Sponsors
Perfect Lens, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent. 2. Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated). 3. Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction. 4. 20/40 or better BCDVA at 4m.
Exclusion criteria
1. Subject not able to complete the informed consent form. 2. Astigmatism greater than 3 diopter. 3. Spherical diopter error of greater than 4 diopters. 4. Combined spherical and cylinder diopter error of greater than 5 diopters. 5. Clinically significant corneal abnormalities including corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion. 6. Previous corneal transplant. 7. Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subject's participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions). 8. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes, including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration. 9. Amblyopia. 10. History of or current anterior or posterior segment inflammation of any etiology, or any disease producing an inflammatory reaction in the eye (e.g. iritis or uveitis). 11. Glaucoma. 12. Optic nerve atrophy. 13. Iris neovascularization. 14. Subjects with diagnosed degenerative eye disorders (e.g. macular degeneration or other retinal disorders). 15. Any subject currently participating in another investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint - Change in mean manifest refraction spherical equivalent ("MRSE") (post- versus pre-treatment) | Between pre-treatment and 1 week post-treatment. | Change in mean manifest refraction spherical equivalent ("MRSE") post-treatment at 7-day visit versus pre-treatment. |
| Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | Demonstrate that mesopic contrast sensitivity (with and without glare) post-treatment (at 7, 30 and 90-day follow up visits) is non-inferior to pre-treatment as measured by CTS contrast sensitivity (NI margin of 0.15 log units). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint - Demonstrate Best Corrected Distance Visual Acuity (BCDVA) (post- versus pre-treatment) | Between pre-treatment and 3 months post-treatment. | Demonstrate that Best Corrected Distance Visual Acuity (BCDVA) at 4m post-treatment (at 90-day visit) is non-inferior to pre-treatment BCDVA (NI margin of 0.1 logMAR, SD=0.12). |
| Secondary Endpoint - Comparison of manifest refraction spherical equivalent (MRSE) (post- versus pre-treatment) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | Comparison of manifest refraction spherical equivalent (MRSE) post-treatment at 7 days, 30 days, and 90 days versus pre-treatment intended MRSE. |
| Secondary Endpoint - Manifest refraction spherical equivalent (MRSE) stability (between any two follow up visits) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | Manifest refraction spherical equivalent (MRSE) remains stable (i.e. within +/-0.5 diopter between any two follow up study visits). |
Countries
Panama
Contacts
PRINCIPAL_INVESTIGATORRuben Orillac, MD, FACS
Panama Eye Center, S.A. (formerly Clinica de Ojos Orillac-Calvo)
Outcome results
None listed