Clinical Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens

Perfect Lens, LLC12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractive Error Correction

Interventions

DeviceOTHER

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Panama Eye Center, S.A. (formerly known as Clinica de Ojos Orillac - Calvo)

Panama City, Panama

Outcomes

Primary Outcomes

Primary Endpoint - Change in mean manifest refraction spherical equivalent ("MRSE") (post- versus pre-treatment)

Change in mean manifest refraction spherical equivalent ("MRSE") post-treatment at 7-day visit versus pre-treatment.

Time frame: Between pre-treatment and 1 week post-treatment.

Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-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).

Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment)

Color vision discrimination compared between pre-op and post-op at 90-day visit (measured by the FM 100 Hue test) comparison of visual disturbances between pre-treatment and post-treatment (at 30 and 90 day-day follow up) assessed via Quality of Vision (QoV) questionnaire.

Time frame: Between pre-treatment and 1 month and 3 months post-treatment.

Secondary Outcomes

Secondary Endpoint - Demonstrate Best Corrected Distance Visual Acuity (BCDVA) (post- versus pre-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).

Time frame: Between pre-treatment and 3 months post-treatment.

Secondary Endpoint - Comparison of manifest refraction spherical equivalent (MRSE) (post- versus pre-treatment)

Comparison of manifest refraction spherical equivalent (MRSE) post-treatment at 7 days, 30 days, and 90 days versus pre-treatment intended MRSE.

Data from ClinicalTrials.gov

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