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PresbyopiaNCT01491360

LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure

A study testing LaserACE(R) in people with Presbyopia, run by ACE Vision Group, Inc. at 1 site in Taiwan.

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

A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Presbyopia
What is being tested?
LaserACE(R)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteTaiwan
Study dates
Dec 2013to Jan 2016
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend postoperative examinations per protocol schedule;
  • 40 years of age or greater, of either gender or any race;
  • Less than (<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
  • Mean refractive spherical equivalent refraction (MRSE) of +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery (LASIK, LASEK or PRK) may qualify; however, the subject must have had the LVC procedure performed at least 12 months prior to the LaserACE® procedure and be stable.
  • Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/32 (logMAR 0.20) in each eye;
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  • Demonstrate Stereopsis of 200 seconds of arc or better using a Randot stereoscopic fly test and reading correction;
  • In good ocular health with the exception of presbyopia;
  • Presbyopia as demonstrated by:
  • Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more; and
  • Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and
  • Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR
  • Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.
  • Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP-lowering medication;
  • Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;
  • Stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the LaserACE® procedure. Manifest refraction cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam;
  • Completed a washout period of two weeks (14 days) prior to LaserACE® procedure from prior treatment with:
  • NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;
  • Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc);
  • Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants.

Who cannot join

  • Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
  • History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
  • Presence of ocular pathology other than cataract such as:
  • Amblyopia or strabismus
  • Corneal abnormalities or disease
  • Dry Eye (International Task Force Level 3 or greater)
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  • Pupil abnormalities (e.g., corectopia, Adie's)
  • Capsule or zonnular abnormalities
  • Intraocular inflammation
  • Retinal disease or pathology
  • Glaucoma (any type)
  • History of prior ocular surgery other than keratorefractive surgery;
  • Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration);
  • Previous radial keratotomy or other corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);
  • Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (< logMAR 0.00) at distance;
  • Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
  • Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
  • Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease);
  • Uncontrolled systemic or ocular disease;
  • Any abnormality preventing reliable applanation tonometry in EITHER eye;
  • Undilatable pupil such that one cannot examine the periphery of the retina;
  • Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
  • History of scleral ectasia, scleritis, or episcleritis; or thin sclera < 400 microns, as determined by taking the average of three measurements with ultrasound biomicroscopy (UBM) pachymetry;
  • History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
  • Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
  • Per PI discretion

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation

A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.

Conditions
Presbyopia
Being tested
LaserACE(R)
Keywords
Presbyopia, sclera, LaserACE
Medical subject headings
Presbyopia

What participants receive

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

  • LaserACE(R)Procedure or surgery

    Also called LaserACE

    Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.

Study groups in NCT01491360
Study groupRoleWhat they receive
LaserACE(R) procedure performedExperimentalThe LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed.
Receives: Procedure: LaserACE(R)

What is being measured

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

  1. Percent of subjects with binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.

    binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.

    Measured: 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 posted14 Dec 2011 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2015
  4. Study completionJan 2016

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01491360
Sponsor's protocol ID
AVG-2013-01
Status last verified
Oct 2021
First submitted
22 Nov 2011
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • Hipsley A, Ma DH, Sun CC, Jackson MA, Goldberg D, Hall B. Visual outcomes 24 months after LaserACE. Eye Vis (Lond). 2017 Jun 16;4:15. doi: 10.1186/s40662-017-0081-y. eCollection 2017.

    PubMed 28812042

Questions about this trial

What is this clinical trial studying?

A study testing LaserACE(R) in people with Presbyopia, run by ACE Vision Group, Inc. at 1 site in Taiwan.

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 20 inclusion and 27 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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.

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?

Percent of subjects with binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm. (time frame: 6 months). 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 NCT01491360, which also lists 1 linked publication.

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 27 Oct 2021.

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