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

• Sponsor: ACE Vision Group, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01491360
• Collaborator: Vision Renu Taiwan Corporation (Industry)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Procedure: LaserACE(R)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LaserACE(R) procedure performed The LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed.	Procedure: LaserACE(R); Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.; Other Names: LaserACE

Outcome Measures

Primary Outcome Measures

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. [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Willing and able to understand and sign an informed consent;

2. Willing and able to attend postoperative examinations per protocol schedule;

3. 40 years of age or greater, of either gender or any race;

4. Less than (<) 1.00D of astigmatism in each eye, measured in their manifest refraction;

5. 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.

6. 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;

7. Demonstrate Stereopsis of 200 seconds of arc or better using a Randot stereoscopic fly test and reading correction;

8. In good ocular health with the exception of presbyopia;

9. Presbyopia as demonstrated by:

10. Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more; and

11. Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and

12. Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR

13. Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.

14. Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP-lowering medication;

15. Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;

16. 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;

17. 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.

Exclusion Criteria

1. Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;

2. History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;

3. 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;

1. 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);

2. Previous radial keratotomy or other corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;

3. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);

4. Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (< logMAR 0.00) at distance;

5. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);

6. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);

7. 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);

8. Uncontrolled systemic or ocular disease;

9. Any abnormality preventing reliable applanation tonometry in EITHER eye;

10. Undilatable pupil such that one cannot examine the periphery of the retina;

11. Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.

12. 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;

13. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;

14. Known allergies to study medications including topical steroids, antibiotics and NSAIDS;

15. Per PI discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taipei		Taiwan

Sponsors and Collaborators

• ACE Vision Group, Inc.
• Vision Renu Taiwan Corporation

Investigators

• Principal Investigator: David Ma, MD, Chang Gung Memorial Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ACE Vision Group, Inc.
• ClinicalTrials.gov Identifier: NCT01491360
• Other Study ID Numbers: AVG-2013-01
• First Posted: Dec 14, 2011
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by ACE Vision Group, Inc.: Presbyopia; sclera; LaserACE
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Oct 27, 2021