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PresbyopiaPhase 3PresbyLASIKNCT00910403

Multicenter Evaluation of Safety and Effectiveness of Presbyopic LASIK for Hyperopes

A Phase 3 study testing LASIK in people with Presbyopia and Hyperopia, run by Technolas Perfect Vision GmbH at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Presbyopia, Hyperopia
What is being tested?
LASIK
Type of treatment
Surgery or procedure
How many people
80 participants
Where
4 sitesin 2 countries
Study dates
Jun 2009to May 2011
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be at least 18 years old
  • Subjects must read, understand, and sign an Informed Consent Form (ICF).
  • Subjects must be willing and able to return for scheduled follow up visits.
  • Subjects must be willing to have both eyes treated during the same visit.
  • Subjects 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 must have presbyopia as determined by an age-related need for optical aid (> +1.50 D) for reading with their best distance correction.
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  • 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.

Who cannot join

  • 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 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.
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  • 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.
  • Exclusion Criteria-For Fellow (Second) Eyes in Simultaneous Bilateral Treatment
  • Procedures:
  • Flap complications during the first eye's surgery such as a free cap, partial flap, thin flap, or irregular flap.
  • Epithelial defect exceeding 2mm x 2mm in dimension, or clinically significant debris in the interface between the flap and underlying stroma for the first eye.
  • Severe blepharospasm in the first eye that may have prevented or impeded the completion of the keratectomy and/or the laser ablation procedure.
  • Poor subject cooperation with instructions for the first eye's surgery and/or poor subject fixation on the laser fixation target.
  • Aborted LASIK procedure in the first eye or PRK or Epi-LASIK was performed in the first eye because LASIK was not possible.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France3 sites

  • Dr. Roure

    Nice, 06000

  • Vision Future Nice

    Nice, 06000

  • Clinique de la Vision Paris

    Paris, 75007

Other trials in France

Spain1 site

  • Instituo Oftalmologico Casteanera

    Barcelona, 08006

Other trials in Spain

About this study

Official title: A Prospective Multicenter, Study to Evaluate the Safety and Effectiveness of the Presbyopia Algorithm for Hyperopia and Hyperopic Astigmatism Using LASIK

The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

Being tested
LASIK
Keywords
Presbyopia, LASIK, Hyperopes
Medical subject headings
Presbyopia, Hyperopia

What participants receive

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

  • LASIKProcedure or surgery

    Also called PresbyLASIK

    Excimer Laser Ablation using LASIK

What is being measured

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

  1. Binocular uncorrected VA better than 20/40

    Measured: 6 M

Secondary outcomes (1)

  1. Percentage of eyes within +/- 1D from target refraction

    Measured: 6M

Timeline

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

  1. First posted29 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMay 2011
  4. Study completionMay 2011

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910403
Sponsor's protocol ID
0901
Acronym
PresbyLASIK
Status last verified
May 2011
First submitted
27 May 2009
Last updated
26 May 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LASIK in people with Presbyopia and Hyperopia, run by Technolas Perfect Vision GmbH at 4 sites in 2 countries.

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 10 inclusion and 26 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: finished, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Binocular uncorrected VA better than 20/40 (time frame: 6 M). 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 NCT00910403.

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 26 May 2011.

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