Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Technolas Perfect Vision GmbH
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01628146
First received: June 6, 2012
Last updated: February 3, 2014
Last verified: June 2013
  Purpose

This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.


Condition Intervention Phase
Hyperopic Presbyopia
Device: SUPRACOR LASIK treatment
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism

Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • High contrast intermediate visual acuity [ Time Frame: The study endpoints will be calculated for the 6-Month follow-up examination. ] [ Designated as safety issue: No ]
    The percentage of treated patients with a binocular uncorrected high contrast intermediate VA of 20/32 (0.4) or better. This percentage should be equal or greater than 60%.


Secondary Outcome Measures:
  • Contrast sensitivity [ Time Frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month. ] [ Designated as safety issue: No ]
    For all treated patients the mean value of the binocular photopic contrast sensitivity (log) for the various spatial frequencies should not decrease more than 0.30.

  • Patient satisfaction [ Time Frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month. ] [ Designated as safety issue: No ]
    The percentage of satisfied patient post SUPRACOR treatment. This percentage should be equal or greater than 75%.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUPRACOR LASIK treatment
SUPRACOR LASIK treatment
Device: SUPRACOR LASIK treatment
The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.
Other Name: LASIK

Detailed Description:

The developed software algorithm SUPRACOR 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 hyperopic cases. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.

Excimer Laser Technolas® 217z100P, High Speed Session Management Software (KERACOR V5.0) and ZYOPTIX Cards as well as all the diagnostic devices that are used in the #1162 study are CE certified and are used for their standard purpose.

This study will be conducted at Mater Private Hospital (Eye Laser Department) by Professor Michael O'Keefe who would recruit up to 40 subjects according to the inclusion/exclusion criteria.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must be at least 48 years old and not older than 65 years
  2. Subjects must read, understand, and sign an Informed Consent Form (ICF).
  3. Subjects must be willing and able to return for scheduled follow up examinations through 6 months after surgery.
  4. Subjects must be willing to have both eyes treated with the laser during the same visit.
  5. Manifest Refraction for both eyes:

    • Sphere: +0.75 D to +5.00 D
    • Cylinder: -2.0 D to 0.0 D
    • Spherical Equivalent: +0.75 D to +4.0 D
  6. Subjects must have presbyopia as determined by an age-related need for optical aid (≥+1.50 D) for reading with their best distance correction
  7. The proper SUPRACOR treatment for the patient must target the dominant eyes for distance at 0.0/ 0.25 dpt and the following eye for near at -0.5/-0.75. The delta between the targets must remain 0.5 dpt
  8. Subjects who have be screened successfully for acceptance of the SUPRACOR simulation
  9. 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.
  10. Corneal topography should be normal.
  11. 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 0.50 D 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.
  12. High contrast, manifest, best spectacle-corrected decimal distance visual acuity (VA) measured with the phoropter must be correctable to at least 1.0 (Snellen20/20 or 6/6) in both eyes.
  13. Mesopic pupil size measured with Zywave II WaveFront Aberrometer and the special Pupil-o-Meter function must be between 3.5mm and 6.5 mm

Exclusion Criteria:

  1. 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.
  2. Subject for whom a flap thickness other than 100-120µm is planed
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Subjects with evidence of retinal vascular disease.
  8. 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.
  9. Subjects with signs of keratoconus.
  10. Subjects with unstable central keratometry readings with irregular mires.
  11. 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.
  12. Subjects who have a history of Herpes simplex or Herpes zoster keratitis.
  13. Subjects who have a history of glaucoma or glaucoma suspect.
  14. 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.
  15. Subjects taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
  16. Subjects who are known to be pregnant, lactating, or who plan to become pregnant during the course of the study.
  17. Subjects with known sensitivity to medications used for standard LASIK.
  18. Subjects participating in any other ophthalmic study during this study.
  19. Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
  20. Subjects at risk for angle closure.
  21. Subjects who have Diabetics
  22. Subjects who have Cataract
  23. Subject who have Dry Eye syndrome as evaluated with the "Tear Break Up-Time (TBUT)" Within this study protocol a TBUT ≥7 seconds is acceptable.

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  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: NCT01628146

Contacts
Contact: Michael O'Keefe, MB, BAO, BcH, FRCS, FRCOphth +353-1-885-86-26 mokeefe@materprivate.ie
Contact: Caroline Baily, MB, BAO, BcH, FRCSH, DOp +353-1-885-86-26 mokeefe@materprivate.ie

Locations
Ireland
Mater Private Hospital, Eye Laser Department Recruiting
Dublin 7, Ireland
Contact: Helen Murphy    +353-1-885-86-26    mokeefe@materprivate.ie   
Contact: Caroline Baily, MB, BAO, BcH    +353-1-885-86-26    mokeefe@materprivate.ie   
Principal Investigator: Michael O'Keefe, MB, BAO, BcH         
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Michael O'Keefe, MB, BAO, BcH Mater Private Hospital, Dublin
  More Information

No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01628146     History of Changes
Other Study ID Numbers: 1162
Study First Received: June 6, 2012
Last Updated: February 3, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Technolas Perfect Vision GmbH:
Presbyopia
hyperopia
Supracor
contrast sensitivity

Additional relevant MeSH terms:
Astigmatism
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 22, 2014