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

NCT01628146 | Unknown Phase 4

• 1 other identifier: 1162
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperopic Presbyopia

Keywords

Presbyopia; hyperopia; Supracor; contrast sensitivity

Outcome Measures

Primary Outcomes (1)

• High contrast intermediate visual acuity

  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%.

  The study endpoints will be calculated for the 6-Month follow-up examination.

Secondary Outcomes (2)

• Contrast sensitivity

  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.

• Patient satisfaction

  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.

Study Arms (1)

SUPRACOR LASIK treatment

EXPERIMENTAL

SUPRACOR LASIK treatment

Device: SUPRACOR LASIK treatment

Interventions

SUPRACOR LASIK treatment DEVICE

The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.

Also known as: LASIK

SUPRACOR LASIK treatment

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 48 years old and not older than 65 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.
• 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
• Subjects must have presbyopia as determined by an age-related need for optical aid (≥+1.50 D) for reading with their best distance correction
• 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
• Subjects who have be screened successfully for acceptance of the SUPRACOR 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 0.50 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.
• 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.

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.
• Subject for whom a flap thickness other than 100-120µm is planed
• 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.

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Mater Private Hospital, Eye Laser Department

Dublin, Ireland

Location

MeSH Terms

Conditions

Presbyopia; Hyperopia

Interventions

Keratomileusis, Laser In Situ

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

Study Officials

• Michael O'Keefe, MB, BAO, BcH

  Mater Private Hospital, Dublin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 26, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

IE (1)