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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error Correction
• Intervention / Treatment: Other: Device

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of Perfector laser treatment; Active treatment arm	Other: Device; 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.; Other Names: Perfector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Between pre-treatment and 1 month and 3 months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

Collaborators and Investigators

• Sponsor: Perfect Lens, LLC
• Investigators: Principal Investigator: Ruben Orillac, MD, FACS, Panama Eye Center, S.A. (formerly Clinica de Ojos Orillac-Calvo)

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies
• Other Study ID Numbers: 35 Perfect Lens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual subject data collected during the trial, after de-identification, will be shared.
• IPD Sharing Time Frame: The individual subject data will be shared upon release of the clinical study report, no end date.
• IPD Sharing Access Criteria: Access will be available for analysis for any purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No