Refractive Error CorrectionNCT07473557
Clinical Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens
A study testing Device in people with Refractive Error Correction, run by Perfect Lens, LLC at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refractive Error Correction
- What is being tested?
- Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePanama
- Study dates
- 18 Jan 2019to 16 Sep 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Amblyopia.
- 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).
- Glaucoma.
- Optic nerve atrophy.
- Iris neovascularization.
- Subjects with diagnosed degenerative eye disorders (e.g. macular degeneration or other retinal disorders).
- Any subject currently participating in another investigational drug or device study.
Trial locations and contacts
1 site in 1 country.
Panama1 site
Panama Eye Center, S.A. (formerly known as Clinica de Ojos Orillac - Calvo)
Panama City
About this study
Official title: A Prospective Study to Assess the Clinical and Refractive Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens
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.
Read the 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.
- Conditions
- Refractive Error Correction
- Being tested
- Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceOther
Also called Perfector
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.
| Study group | Role | What they receive |
|---|---|---|
| Application of Perfector laser treatment | Experimental | Active treatment arm Receives: Other: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Between pre-treatment and 1 month and 3 months post-treatment.
Secondary outcomes (3)
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).
Measured: 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.
Measured: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Secondary Endpoint - Manifest refraction spherical equivalent (MRSE) stability (between any two follow up visits)
Manifest refraction spherical equivalent (MRSE) remains stable (i.e. within +/-0.5 diopter between any two follow up study visits).
Measured: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start18 Jan 2019
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive Error CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perfect Lens, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Orillac, MD, FACS, Principal investigator, Panama Eye Center, S.A. (formerly Clinica de Ojos Orillac-Calvo)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473557
- Sponsor's protocol ID
- 35 Perfect Lens
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual subject data collected during the trial, after de-identification, will be shared.