CompletedNot Applicable

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

Panama12 participantsStarted 2019-01-18

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated).
✓. Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction.
✓. 20/40 or better BCDVA at 4m.

Exclusion criteria

✕. Subject not able to complete the informed consent form.
✕. Astigmatism greater than 3 diopter.
✕. Spherical diopter error of greater than 4 diopters.
✕. Combined spherical and cylinder diopter error of greater than 5 diopters.
✕. 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.
✕. Previous corneal transplant.
✕. 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).
✕. 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.

What they're measuring

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

Timeframe: Between pre-treatment and 1 week post-treatment.

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

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

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

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

Trial details

NCT IDNCT07473557

SponsorPerfect Lens, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-16

View on ClinicalTrials.gov More Refractive Error Correction trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated).
✓. Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction.
✓. 20/40 or better BCDVA at 4m.

Exclusion criteria

✕. Subject not able to complete the informed consent form.
✕. Astigmatism greater than 3 diopter.
✕. Spherical diopter error of greater than 4 diopters.
✕. Combined spherical and cylinder diopter error of greater than 5 diopters.
✕. 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.
✕. Previous corneal transplant.
✕. 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).
✕. 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.

What they're measuring

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

Timeframe: Between pre-treatment and 1 week post-treatment.

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

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

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

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