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

NCT01491360 | Completed

• 1 other identifier: AVG-2013-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia

Keywords

Presbyopia; sclera; LaserACE

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (1)

LaserACE(R) procedure performed

EXPERIMENTAL

The LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed.

Procedure: LaserACE(R)

Interventions

LaserACE(R) PROCEDURE

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

Also known as: LaserACE

LaserACE(R) procedure performed

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and sign an informed consent;
• Willing and able to attend postoperative examinations per protocol schedule;
• 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;
• 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;

You may not qualify if:

• 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)
• 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);

Sponsors & Collaborators

• ACE Vision Group, Inc.: lead
• Vision Renu Taiwan Corporation: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28812042 DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• David Ma, MD

  Chang Gung Memorial Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

TW (1)