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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of Perfector laser treatment | Experimental | Active treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Orillac, MD, FACS | Panama Eye Center, S.A. (formerly Clinica de Ojos Orillac-Calvo) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panama Eye Center, S.A. (formerly known as Clinica de Ojos Orillac - Calvo) | Panama City | Panama |
All of the individual subject data collected during the trial, after de-identification, will be shared.
The individual subject data will be shared upon release of the clinical study report, no end date.
Access will be available for analysis for any purpose.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| 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. |