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

NCT07473557 | Completed

• 1 other identifier: 35 Perfect Lens
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Error Correction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  Between pre-treatment and 3 months post-treatment.

• 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.

• 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.

Study Arms (1)

Application of Perfector laser treatment

EXPERIMENTAL

Active treatment arm

Other: Device

Interventions

Device OTHER

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.

Also known as: Perfector

Application of Perfector laser treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• /40 or better BCDVA at 4m.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Perfect Lens, LLC: lead

Study Sites (1)

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

Panama City, Panama

Location

MeSH Terms

Interventions

Equipment and Supplies

Study Officials

• Ruben Orillac, MD, FACS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: January 18, 2019
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The individual subject data will be shared upon release of the clinical study report, no end date.
• Access Criteria: Access will be available for analysis for any purpose.

Locations

PA (1)