NCT01977807

Brief Summary

This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

October 31, 2013

Last Update Submit

May 19, 2015

Conditions

MyopiaHyperopiaPresbyopia

Keywords

MyopiaHyperopiaPresbyopiaSupracorZyoptixProscanLASIK

Outcome Measures

Primary Outcomes (1)

  • For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better

    Myopia: 6 months, Hyperopia 12 months

Study Arms (2)

Myopia

EXPERIMENTAL

Myopia Lasik treatment of virgin eyes.

Device: Proscan, Zyoptix and Supracor

Hyperopia

EXPERIMENTAL

Hyperopia Lasik treatment of virgin eyes.

Device: Proscan, Zyoptix and Supracor

Interventions

Proscan, Zyoptix and SupracorDEVICE

One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)

HyperopiaMyopia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects have to be at least 18 years of age.
  • Subjects have to be able to read, understand, and sign a statement of Informed Consent.
  • Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 and 12 months respectively after surgery.
  • Corneal topography should be qualified
  • High contrast, manifest, best spectacle-corrected distance visual acuity correctable binocular to at least 1.0 (Snellen 20/20 or 6/6) and monocular to at least 0.8 (Snellen 20/25 or 6/7.5). In case of a monocular surgery the eye which should not be treated must have a best corrected distance visual acuity of at least 0.8 (Snellen 20/25 or 6/7.5).
  • Mesopic pupil size measured with the Zywave II WaveFront Aberrometer must be \< 7.0 mm and photopic pupil size measured with the Orbscan II/ IIz must be \> 2.9 mm.
  • For Proscan myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
  • For Proscan hyperopic subjects require a sphere between +0.5 D up to +4.0 D and cylinder between +0.5 D up to +4.0 D (not corneal astigmatism) and SE up to +6.0 D.
  • For Zyoptix myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
  • For Zyoptix hyperopic subjects require a sphere between +0.5 D up to +4.0 D and cylinder between +0.5 D up to +4.0 D (not corneal astigmatism) and SE up to +6.0 D.
  • For all treatments with the Zyoptix algorithm, the high-order-aberration must be at least 0.35µm.
  • For treatments with the SUPRACOR presbyopic algorithm, subjects have to be at least 45 years old and no more than 85 years
  • Myopic subjects must have up to -7.0 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent and must be no more than -9.0 D.
  • Hyperopic subjects must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 D.
  • Subjects must have presbyopia as determined by an age-related need for optical aid(\> +1.50 D) for reading with their best distance correction and been screened success-fully for acceptance of the SUPRACOR simulation.

You may not qualify if:

  • 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 posterior corneal thickness below the flap postoperatively.
  • Hyperopic eyes for which the baseline manifest subjective refraction exhibits a difference of greater than ± 0.75 D in sphere power, or a difference of greater than ± 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than ±0.75 D, the differ-ence in cylinder axis would not be taken into consideration.
  • Subjects with anterior segment pathology, including dry eye syndrome and cataracts, which in the Investigator's opinion would interfere with best spectacle-corrected visual acuity or a successful treatment.
  • Subjects with evidence of retinal vascular disease. Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
  • Subjects with signs of keratoconus or Subjects with unstable central keratometry readings with irregular mires.
  • Subjects who had previous intraocular or corneal surgery of any kind, including any type of Excimer laser surgery for either refractive or therapeutic purposes.
  • Subjects who have a history of Herpes simplex or Herpes zoster keratitis or history of glaucoma or glaucoma suspect, corneal edema, or increased IOP \> 22mmHg or risk for angle closure.
  • Subjects immunocompromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
  • Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the course of the study.
  • Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
  • Subjects with cognitive impairments or other vulnerable persons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Eye Institut

Manila, 1200, Philippines

RECRUITING

MeSH Terms

Conditions

MyopiaHyperopiaPresbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Robert Ang, M.D.

    Asian Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiela De Castro

CONTACT

0915-267-0541SSDeCastro@asianeyeinstitute.com

Gino Lagrosa

CONTACT

: +6328982020 Ext. 510 / 109

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

PH(1)