Peripheral PresbyLASIK Using the Allegretto Wavelight System For The Treatment of Presbyopia

NCT01059006 | Withdrawn

• 1 other identifier: 091460
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to analyze the results of PresbyLASIK performed using the wavefront-optimized LASIK for the treatment of presbyopia on low hyperopic and low myopic patients with astigmatism. Visual performance will be assessed using clinical outcome measures of the following: refraction, near, intermediate and distance visual acuity, stereoacuity and contrast sensitivity. Questionnaires will also be used to evaluate how the patient's vision is before and after surgery.

Conditions

Refractive Error; Presbyopia

Keywords

Reflective Surgery; Presbyopia; PresbyLASIK

Outcome Measures

Primary Outcomes (5)

• Uncorrected near visual acuity

  1 Day, 1 Week, 3 and 6 Months

• Best corrected near visual acuity

  1 Day, 1 Week, 3 and 6 Months

• Intermediate visual acuity

  1 Day, 1 Week, 3 and 6 Months

• Stereoacuity test

  1 Day, 1 Week, 3 and 6 Months

• Psychometric questionnaire

  1 Day, 1 Week, 3 and 6 Months

Study Arms (1)

PresbyLASIK

EXPERIMENTAL

Male or female patients with presbyopic symptoms who underwent PresbyLASIK.

Procedure: PresbyLASIK

Interventions

PresbyLASIK PROCEDURE

PresbyLASIK essentially involves the creation of a multifocal surface able to correct any visual defect for distance while simultaneously allowing freedom from near spectacle dependency in presbyopic patients.

Also known as: Presbyopia, Presbyopic Symptoms

PresbyLASIK

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any race, and at least 35 to 80 years old with significant presbyopic symptoms at the time of the preoperative examination, and have signed an informed consent. The lower age limit of 35 is the earliest age in which reduction in accommodation occurs.
• Refractive error between +3.00 to -5.00 diopters (D) sphere at the spectacle plane with no more than 3.00D of refractive astigmatism (negative cylinder format)
• Best spectacle corrected visual acuity of at least 20/20 and J3 in both eyes.
• Residual corneal bed thickness of ≥ to 330 microns
• Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination.
• Soft contact lens users must have removed their lenses at least one week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 diopter in either meridian; mires should be regular.
• Located in the greater San Diego area for a 6-month period.
• Exhibit strong motivation for attending the follow-up visits.
• Access to transportation to meet follow-up requirements.

You may not qualify if:

• Patients that have previously been treated for refractive surgery (LASIK and/or PRK)
• Patients with known history or have concurrent dry eye disease (e.g. keratoconjunctivitis sicca)
• Patients who have less than 5 mm pupil size in dimlight
• Female subjects who are pregnant, breast-feeding or intend to become pregnant during the first six months of the study.
• Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatriptan (Imitrex) or any other triptan.
• Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
• Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or lens opacity.
• Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
• Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
• Corneal thickness insufficient to allow the residual remaining stromal bed to be at least 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (6)

• Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.

  PMID: 19603619 BACKGROUND

• Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.

  PMID: 19537363 BACKGROUND

• Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.

  PMID: 18494342 BACKGROUND

• Illueca C, Alio JL, Mas D, Ortiz D, Perez J, Espinosa J, Esperanza S. Pseudoaccommodation and visual acuity with Technovision presbyLASIK and a theoretical simulated Array multifocal intraocular lens. J Refract Surg. 2008 Apr;24(4):344-9. doi: 10.3928/1081597X-20080401-05.

  PMID: 18500082 BACKGROUND

• Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.

  PMID: 17269242 BACKGROUND

• Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006 May;22(5):453-60. doi: 10.3928/1081-597X-20060501-06.

  PMID: 16722483 BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• David J Schanzlin, MD

  UCSD Shiley Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 5, 2011

Record last verified: 2011-08