Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01491360
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Presbyopia', 'sclera', 'LaserACE'], 'conditions': ['Presbyopia']}, 'referencesModule': {'references': [{'pmid': '28812042', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Willing and able to understand and sign an informed consent;\n2. Willing and able to attend postoperative examinations per protocol schedule;\n3. 40 years of age or greater, of either gender or any race;\n4. Less than (\\<) 1.00D of astigmatism in each eye, measured in their manifest refraction;\n5. 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.\n6. 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;\n7. Demonstrate Stereopsis of 200 seconds of arc or better using a Randot stereoscopic fly test and reading correction;\n8. In good ocular health with the exception of presbyopia;\n9. Presbyopia as demonstrated by:\n\n 1. Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more; and\n 2. Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and\n 3. Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR\n 4. Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.\n10. Intraocular pressure (IOP) \\>11mmHg and \\< 30 mmHg in each eye without IOP-lowering medication;\n11. Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;\n12. 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;\n13. Completed a washout period of two weeks (14 days) prior to LaserACE® procedure from prior treatment with:\n\n * NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;\n * Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc);\n * Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants.\n\nExclusion Criteria\n\n1. Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;\n2. History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;\n3. Presence of ocular pathology other than cataract such as:\n\n * Amblyopia or strabismus\n * Corneal abnormalities or disease\n * Dry Eye (International Task Force Level 3 or greater)\n * Pupil abnormalities (e.g., corectopia, Adie's)\n * Capsule or zonnular abnormalities\n * Intraocular inflammation\n * Retinal disease or pathology\n * Glaucoma (any type)\n * History of prior ocular surgery other than keratorefractive surgery;\n4. 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);\n5. Previous radial keratotomy or other corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;\n6. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);\n7. Keratoconus or keratoconus suspect with CDVA of less than (\\<) 20/20 (\\< logMAR 0.00) at distance;\n8. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);\n9. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);\n10. 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);\n11. Uncontrolled systemic or ocular disease;\n12. Any abnormality preventing reliable applanation tonometry in EITHER eye;\n13. Undilatable pupil such that one cannot examine the periphery of the retina;\n14. Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.\n15. 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;\n16. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;\n17. Known allergies to study medications including topical steroids, antibiotics and NSAIDS;\n18. Per PI discretion"}, 'identificationModule': {'nctId': 'NCT01491360', 'briefTitle': 'LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACE Vision Group, Inc.'}, 'officialTitle': 'Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation', 'orgStudyIdInfo': {'id': 'AVG-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LaserACE(R) procedure performed', 'description': 'The LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed.', 'interventionNames': ['Procedure: LaserACE(R)']}], 'interventions': [{'name': 'LaserACE(R)', 'type': 'PROCEDURE', 'otherNames': ['LaserACE'], 'description': 'Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.', 'armGroupLabels': ['LaserACE(R) procedure performed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'David Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital, Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ACE Vision Group, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vision Renu Taiwan Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}