Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-30 @ 12:41 PM
Study NCT ID:
NCT04738903
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Q value', 'timeFrame': '6 months', 'description': 'Pentacam evaluation of post-LASIK Q value'}], 'secondaryOutcomes': [{'measure': 'Postoperative corneal thickness at the pupillary center', 'timeFrame': '6 months', 'description': 'Pentacam evaluation of post-LASIK pachymetry at the pupil center'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Femtosecond LASIK', 'Q value', 'Wave-front Optimized (WFO)'], 'conditions': ['Patients With Myopic Spherical Equivalent up to -12 Diopters']}, 'referencesModule': {'references': [{'pmid': '28187180', 'type': 'BACKGROUND', 'citation': 'Piao J, Li YJ, Whang WJ, Choi M, Kang MJ, Lee JH, Yoon G, Joo CK. Comparative evaluation of visual outcomes and corneal asphericity after laser-assisted in situ keratomileusis with the six-dimension Amaris excimer laser system. PLoS One. 2017 Feb 10;12(2):e0171851. doi: 10.1371/journal.pone.0171851. eCollection 2017.'}, {'pmid': '36320050', 'type': 'DERIVED', 'citation': 'Mostafa MM, Abdelmotaal H, Abdelazeem K, Goda I, Abdel-Radi M. Q-value customized versus wavefront-optimized ablation in femtosecond laser-assisted LASIK for myopia and myopic astigmatism: a prospective contralateral comparative study. Eye Vis (Lond). 2022 Nov 2;9(1):43. doi: 10.1186/s40662-022-00312-3.'}]}, 'descriptionModule': {'briefSummary': 'Corneal asphericity is expressed numerically as the "Q-value". A minus value means that corneal curvature flattens towards the periphery and the cornea is prolate in shape, but when the curvature steepens towards the periphery, the cornea is oblate in shape and has a positive Q-value.\n\nThe current study evaluates the effect of LASIK eye surgery on corneal asphericity by comparing 2 software treatment platforms; the Q value customized ablation versus the conventional Wave-front optimized ablation in a fellow eye study pattern.', 'detailedDescription': 'The standard excimer laser correction of myopia is associated with decreased visual quality in the form of a decrease in contrast sensitivity and night vision. This degradation of the visual quality is attributed to changes in the corneal asphericity that increase the high order aberrations (HOAs), such as spherical aberrations because it leads to shifting of the corneal asphericity towards the oblate shape.\n\nThe wavefront-optimized (WFO) profile avoids the creation of new HOAs, but it is not able to treat those which are already present pre-operatively.\n\nThe Q-adjusted treatments correct the sphero-cylindrical refractive errors and try to maintain the corneal asphericity at the same time, but like the WFO ablation profiles, it is limited to correcting the spherical aberrations and not the non-rotational symmetric HOAs.\n\nSome studies compared Lasers of two different platforms on contralateral eyes of the same patient in order to minimize inter-patient differences such as corneal wound healing and corneal biomechanics. By exclusion of these inter-patient differences, a more accurate judgment on the outcomes can be achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Candidates for Laser vision correction (LVC) with\n\n1. Myopic Spherical Equivalent up to -12 diopters.\n2. Myopic astigmatism up to -6 diopters.\n3. Corneal thinnest location ≥ 500 um 4- Residual stromal bed ≥ 300 um.\n\nExclusion Criteria:\n\n1. Patients not candidates for LVC.\n2. Hyperopic patients or mixed astigmatism.\n3. Systemic disease that contraindicates LVC.\n4. Intra- or post-operative complications. 5- Previous corneal surgery'}, 'identificationModule': {'nctId': 'NCT04738903', 'briefTitle': 'Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK for Myopia and Myopic Astigmatism. A Contralateral Comparative Study', 'orgStudyIdInfo': {'id': 'CQLASIK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Custom Q treatment group', 'description': 'For every patient, the eye with the greater myopic spherical equivalent (SE) will be assigned for the Custom-Q treatment group.', 'interventionNames': ['Procedure: Femtosecond laser assisted LASIK eye surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wave-front optimized (WFO) group', 'description': 'For every patient, the other eye with the lesser myopic SE will be assigned for the WFO treatment group', 'interventionNames': ['Procedure: Femtosecond laser assisted LASIK eye surgery']}], 'interventions': [{'name': 'Femtosecond laser assisted LASIK eye surgery', 'type': 'PROCEDURE', 'description': "FS-LASIK eye surgery includes corneal flap creation with femtosecond laser using the Femtosecond laser WaveLight FS200 followed by excimer laser vision correction of the patient's refractive error using excimer laser WaveLight EX500.", 'armGroupLabels': ['Custom Q treatment group', 'Wave-front optimized (WFO) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71516', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'TIBA eye center', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mahmoud Abdel-Radi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahmoud Abdel-Radi', 'investigatorAffiliation': 'Assiut University'}}}}