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Refractive ErrorNCT01059006

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

A study testing PresbyLASIK in people with Refractive Error and Presbyopia, run by University of California, San Diego.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Refractive Error, Presbyopia
What is being tested?
PresbyLASIK
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2010to Jul 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
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  • 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

About this study

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.

Read the detailed description

Presbyopia is a physiologic change related to age in which there is reduction in the eye's ability to focus in order to obtain clear vision for near distance. At approximately age 40 the range of accommodation begins to decrease and there is a diminishing capacity of the eye to focus on the nearest point it can focus on. This makes the need for corrective lenses a necessity in order to read at near as well as focus at an intermediate distance.

Presbyopia correction is one of the most frequently discussed topics in refractive surgery today. The idea of a creating a multifocal cornea using refractive surgery has sparked tremendous interest in finding a solution for this growing population throughout the world, especially amongst surgeons and the ophthalmic industry

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. PresbyLASIK is currently being offered routinely to patients in the San Diego area, across the country as well as in numerous centers around the world.

Conclusions from this study would serve as a guide for keratorefractive surgeons, who are pursuing peripheral PresbyLASIK, in determining the preoperative patient features in order to achieve the best outcome using the Wavelight-Allegretto System.

Being tested
PresbyLASIK
Keywords
Reflective Surgery, Presbyopia, PresbyLASIK
Medical subject headings
Refractive Errors, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PresbyLASIKProcedure or surgery

    Also called Presbyopia, Presbyopic Symptoms

    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.

Study groups in NCT01059006
Study groupRoleWhat they receive
PresbyLASIKExperimentalMale or female patients with presbyopic symptoms who underwent PresbyLASIK.
Receives: Procedure: PresbyLASIK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uncorrected near visual acuity

    Measured: 1 Day, 1 Week, 3 and 6 Months

  2. Best corrected near visual acuity

    Measured: 1 Day, 1 Week, 3 and 6 Months

  3. Intermediate visual acuity

    Measured: 1 Day, 1 Week, 3 and 6 Months

  4. Stereoacuity test

    Measured: 1 Day, 1 Week, 3 and 6 Months

  5. Psychometric questionnaire

    Measured: 1 Day, 1 Week, 3 and 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2010
  4. Study completionJul 2010

Why it stopped: Lead researcher completed fellowship and never got study off ground

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01059006
Sponsor's protocol ID
091460
Status last verified
Aug 2011
First submitted
28 Jan 2010
Last updated
5 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19603619

  • 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.

    PubMed 19537363

  • 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.

    PubMed 18494342

  • 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.

    PubMed 18500082

  • 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.

    PubMed 17269242

  • 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.

    PubMed 16722483

Questions about this trial

What is this clinical trial studying?

A study testing PresbyLASIK in people with Refractive Error and Presbyopia, run by University of California, San Diego.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected near visual acuity (time frame: 1 Day, 1 Week, 3 and 6 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01059006, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.

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