A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

NCT01699087 | Completed Results

• 1 other identifier: C-10-084
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in subjects undergoing photorefractive keratectomy (PRK) treatment.

Conditions

Myopia; Astigmatism

Keywords

PRK; myopia; astigmatism

Outcome Measures

Primary Outcomes (10)

• Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively

  Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.

  Month 6 (post second eye surgery)

• Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability

  Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

  Month 6 (post second eye surgery)

• Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability

  Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

  Month 6 (post second eye surgery)

• Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability

  Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.

  Month 6 (post second eye surgery)

• Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability

  Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.

  Month 6 (post second eye surgery)

• Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits

  MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

  Up to Month 24 (post second eye surgery)

• Cumulative Incidence of Ocular Serious Adverse Events by Eye

  Participants were followed for the duration of the study, an expected average of 24 months.

  Up to Month 24 (post second eye surgery)

• Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability

  Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).

  Month 6 (post second eye surgery)

• Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability

  Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .

  Month 6 (post second eye surgery)

• Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability

  Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.

  Month 6 (post second eye surgery)

Study Arms (1)

PRK ALLEGRETTO

EXPERIMENTAL

Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation

Procedure: Photorefractive keratectomy (PRK); Device: ALLEGRETTO WAVE EYE-Q excimer laser system

Interventions

Photorefractive keratectomy (PRK) PROCEDURE

In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.

PRK ALLEGRETTO

ALLEGRETTO WAVE EYE-Q excimer laser system DEVICE

The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery

Also known as: ALLEGRETTO WAVE Eye-Q, WaveLight® EX500, WaveNet™ Planning Software, ALLEGRETTO WAVE® EYE-Q excimer laser system (Model 1010-3)

PRK ALLEGRETTO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects desiring refractive correction of myopia up to -6.00 Diopter (D) sphere with or without astigmatism 0 to -3.00 D and up to -6.00 D manifest refraction spherical equivalent (MRSE) at the spectacle plane measured by manifest refraction;
• Minimum best spectacle corrected visual acuity (BSCVA) in the treated eye of 20/25;
• Uncorrected visual acuity (UCVA) 20/40 or worse in the treated eye;
• Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions;
• Stable refraction (within ± 0.5 D), as determined by MRSE for a minimum of 12 months prior to surgery;
• Demonstrated stable refraction for contact lens wearers, as specified in protocol;
• Signed informed consent document;
• Willing and able to comply with schedule for follow-up visits;

You may not qualify if:

• Females who are pregnant, lactating, or planning a pregnancy during the time course of the study, or have another condition associated with the fluctuation of hormones that could lead to refractive changes;
• Participation in other clinical trials during this study;
• Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
• Dry eye syndrome as determined by the short questionnaire for dry eye syndrome;
• Systemic medications that may confound the outcome of the study or increase the risk to the subject by affecting wound healing or tissue repair, including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.;
• Nystagmus or any other condition that would prevent a steady gaze during the PRK treatment or other diagnostic tests;
• Ocular condition that may predispose the subject to future complications;
• Previous intraocular or corneal surgery;
• Subjects who desire to have monovision;
• A known sensitivity to medications used for study procedures, including PRK;
• Presence or history of any condition or finding that makes the subject unsuitable as a candidate for PRK or study participation or may confound the outcome of the study, in the opinion of the Investigator;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Photorefractive Keratectomy

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Results Point of Contact

• Title: Expert Clinical Project Lead, GCRA, Surgical
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Manager, GCRA Surgical

  Alcon, a Novartis Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 27, 2012
• First Posted: October 3, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 30, 2019
• Results First Posted: April 10, 2017

Record last verified: 2018-05