Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure (Supracor)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Technolas Perfect Vision GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01322919
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.

This study will help us to answer 2 questions:

  1. How accurately this combined technique corrects distance and near vision
  2. Whether the correction is adequate to remove the complete need for supplementary near spectacles

Condition Intervention Phase
Myopia
Hyperopia
Presbyopia
Refractive Error
Procedure: Supracor
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Safety and Effectiveness of the Presbyopic LASIK Algorithm

Resource links provided by NLM:


Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • The percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of treated eyes within +/- 1.00D of target refraction [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • The percentage of treated eyes within +/- 0.50D of target refraction [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • The percentage of treated eyes with a monocular uncorrected high contrast distance VA of 20/40 or better [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Preservation of VA: Loss of more than 2 lines in monocular BCVA for distance vision [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myopic Treatment Arm
Patients treated in this arm will have preoperative measurements that indicate a myopic condition of the eye in conjunction with a presbyopic condition
Procedure: Supracor

All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components.

The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases.

In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.

Other Names:
  • Myopia
  • Hyperopia
  • Presbyopia
  • PresbyLASIK
  • LASIK
  • Supracor
Experimental: Hyperopic Treatment Arm
Patients treated in this arm will have preoperative measurements that indicate a hyperopic condition of the eye in conjunction with a presbyopic condition
Procedure: Supracor

All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components.

The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases.

In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.

Other Names:
  • Myopia
  • Hyperopia
  • Presbyopia
  • PresbyLASIK
  • LASIK
  • Supracor

Detailed Description:

LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual correction. Typically, this procedure will only correct your long distance vision requiring the use of supplementary spectacles for reading and near vision.

The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the European Community for both treatment versions to correct separately the near vision and the distance vision for cases which need one or the other correction.

By using a new software two consecutive treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.

This study will help us to answer 2 questions:

  1. How accurately this combined technique corrects distance and near vision
  2. Whether the correction is adequate to remove the complete need for supplementary near spectacles
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be at least 45 years old and not older than 85 years
  • 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 be willing to have both eyes treated with the laser during the same visit.
  • Subjects for study arm-I 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 for study arm-II must have up to -7 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 in both eyes. The spherical equivalent must be no more than -9.00 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.
  • Subjects who have been screened successfully for acceptance of the PresbyLasik simulation
  • Subjects who are contact lens wearers must have gas permeable (GP) lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the preoperative evaluation in the eye to be treated. Contact lens wearers who wear their contact lenses for any amount of time between the preoperative baseline examination and the operative visit must not be treated.
  • Corneal topography should be normal.
  • Subjects who are contact lens wearers must have 2 central keratometry readings and 2 manifest subjective refractions taken preoperatively at least one week apart. The refraction values must not differ by more than 0.50D as defined by manifest refraction spherical equivalent (MRSE). The keratometry values must not differ from the previous values by more than 0.50D in either meridian.
  • High contrast, manifest, best spectacle-corrected logMAR distance visual acuity (VA) must be correctable to at least 0.1 (20/25 or 6/7.5) in both eyes.

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 posterior corneal thickness below the flap postoperatively.
  • Eyes for which the baseline manifest subjective refraction exhibits a difference of greater than 0.75D in sphere power, or a difference of greater than 0.50D 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 0.75D, the difference in cylinder axis will not be taken into consideration.
  • 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.
  • Any subject who is going to be co-managed by an ophthalmologist or optometrist who is not approved as a Technolas Perfect Vision GmbH Excimer laser Investigator.
  • Subjects with anterior segment pathology, including dry eye syndrome and cataracts which in the Investigator's opinion, would interfere with best spectacle-corrected VA (BSCVA) 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.
  • Subjects with unstable central keratometry readings with irregular mires.
  • Subjects who have undergone 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.
  • Subjects who have a history of glaucoma or glaucoma suspect.
  • Subjects who are 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.
  • Subjects taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
  • Subjects who are known to be pregnant, lactating, or who plan to become pregnant during the course of the study.
  • Subjects with known sensitivity to medications used for standard LASIK.
  • Subjects participating in any other ophthalmic clinical trials during this clinical trial.
  • Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
  • Subjects at risk for angle closure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322919

Contacts
Contact: Enrique Barragan, M.D. +5280040587 ext 118 ebarragan@me.com
Contact: Carolina Farill +5280040587 ext 118 laser.ocular.hidalgo@gmail.com

Locations
Mexico
Laser Ocular Hidalgo Recruiting
Monterrey, N.l., Mexico, 64060
Contact: Carolina Farill    +5280040587 91 ext 118    laser.ocular.hidalgo@gmail.com   
Contact: Martha Ciencias       mvcesena@hotmail.com   
Principal Investigator: Enrique Barragan, M.D.         
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Enrique Barragan, M.D. Laser Ocular Hidalgo
  More Information

Publications:
Responsible Party: Dr. Gerhard Youssefi, Vice President, Research & Clinical Operations, Technolas Perfect Vision, GmbH
ClinicalTrials.gov Identifier: NCT01322919     History of Changes
Other Study ID Numbers: 1001
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: Mexico: Secretaria de Salud
Mexico: Ethics Committee

Keywords provided by Technolas Perfect Vision GmbH:
PresbyLASIK
Presbyopia
LASIK
Supracor
refractive
Myopia
Hyperopia

Additional relevant MeSH terms:
Refractive Errors
Presbyopia
Hyperopia
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014