Near and Intermediate Vision and Binocular Defocus Curves Before and After the LaserACE® Procedure
This study is enrolling participants by invitation only.
Sponsor:
ACE Vision Group, Inc.
Collaborator:
Vision Renu Taiwan Corporation
Information provided by (Responsible Party):
ACE Vision Group, Inc.
ClinicalTrials.gov Identifier:
NCT01491360
First received: November 22, 2011
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Presbyopia |
Procedure: LaserACE(R) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Near and Intermediate Vision and Binocular Defocus Curves Before and After the LaserACE® Procedure |
Further study details as provided by ACE Vision Group, Inc.:
Primary Outcome Measures:
- Change in uncorrected near visual acuity [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]Uncorrected high contrast logMAR visual acuity at 40cm compared to preoperative
- Change in uncorrected intermediate visual acuity [ Time Frame: preoperative, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]High contrast uncorrected logMAR visual acuity at 60cm
Secondary Outcome Measures:
- Binocular defocus curve [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]Binocular defocus curve compared to preoperative
- Intraocular pressure [ Time Frame: Preoperative, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: LaserACE
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Are willing and able to understand and sign an informed consent
- Are willing and able to attend postoperative examinations per protocol schedule
- Are more than 40 years of age, of either gender and any race
- Have ≤1 D of preoperative refractive astigmatism in both eyes, measured in their manifest refraction
- Have a mean spherical equivalent refraction of +/- 0.50D for distance vision. Patients who meet this criterion as a result of prior laser refractive surgery (LASIK or PRK) are eligible for inclusion
- Have demonstrated stereoacuity of 100 seconds of arc or better, using a standard stereoscopic test
- Are in good ocular health, with the exception of presbyopia;
- have a demonstrated loss of accommodative range as evidenced by reduced near vision when corrected for distance
Exclusion Criteria:
- Amblyopia
- Previous radial keratotomy, or other corneal surgery besides LASIK or PRK (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular degeneration
- Subjects with pupil abnormalities (e.g., corectopia)
- History of retinal detachment
- Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- Keratoconus
- Near vision at 40cm equivalent to their distance vision when corrected for distance (i.e., no evident effect of reduced accommodative range).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491360
Locations
| Taiwan | |
| 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 |
More Information
No publications provided
| Responsible Party: | ACE Vision Group, Inc. |
| ClinicalTrials.gov Identifier: | NCT01491360 History of Changes |
| Other Study ID Numbers: | AVG-2011-02 |
| Study First Received: | November 22, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by ACE Vision Group, Inc.:
|
Presbyopia sclera LaserACE |
Additional relevant MeSH terms:
|
Presbyopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013