Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

Phase 4

Completed

• Conditions: Myopia; Hyperopia; Presbyopia
• Interventions: Device: Supracor

• Registration Number: NCT01387360
• Lead Sponsor: Technolas Perfect Vision GmbH

Brief Summary

This clinical study has been planned to determine the effectiveness of a special laser treatment intended to correct both near and distance vision in patients who have undergone previous cataract surgery.

Detailed Description

This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications, with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with a monofocal IOL.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-04
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Subjects must be at least 45 years old
• Subjects must read, understand, and sign an Informed Consent Form (ICF).
• Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery.
• Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment.
• Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D.
• Subjects who have be screened successfully for acceptance of the SUPRACOR simulation

Exclusion Criteria

• Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining corneal thickness below the flap postoperatively.
• Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supracor	Supracor	Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.

Primary Outcome Measures

Name	Time	Method
The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better	6M

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of AEs	6M
The percentage of treated eyes within +/- 1.00D of target refraction	6M
The percentage of treated eyes within +/- 0.50D of target refraction	6M
The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better	6M
Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits	6M
Preservation of VA: Loss of more than 2 lines in BCVA for distance vision	6M
The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better	6M
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D	6M
Cumulative incidence subjective symptoms	6M

Trial Locations

Locations (1)

Asian Eye Institute; 🇵🇭 Makati, Manila, Philippines