Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04676620
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Anterior Corneal Optical Aberration Induced by CK and Hyperopic LASIK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uncorrected visual acuity', 'timeFrame': 'change from baseline with EDTRS chart at 6 months', 'description': 'uncorrected visual acuity change from baseline at 6 months'}, {'measure': 'best spectacle-corrected visual acuity', 'timeFrame': 'change from baseline with EDTRS chart at 6 months', 'description': 'best spectacle-corrected visual acuity change from baseline with EDTRS chart at 6 months'}], 'secondaryOutcomes': [{'measure': 'near vision', 'timeFrame': 'change from baseline with EDTRS chart at 6 months', 'description': 'near vision change from baseline with EDTRS chart at 6 months'}, {'measure': 'central and peripheral corneal ultrasound pachymetry', 'timeFrame': 'change from baseline with EDTRS chart at 6 months', 'description': 'central and peripheral corneal ultrasound pachymetry change from baseline with EDTRS chart at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['conductive keratoplasty', 'corneal optical aberrations', 'hyperopic corrections', 'LASIK'], 'conditions': ['Refractive Error']}, 'referencesModule': {'references': [{'pmid': '17568211', 'type': 'RESULT', 'citation': 'Du TT, Fan VC, Asbell PA. Conductive keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):334-7. doi: 10.1097/ICU.0b013e3281df2cf0.'}, {'pmid': '14709295', 'type': 'RESULT', 'citation': 'Lin DY, Manche EE. Two-year results of conductive keratoplasty for the correction of low to moderate hyperopia. J Cataract Refract Surg. 2003 Dec;29(12):2339-50. doi: 10.1016/j.jcrs.2003.09.022.'}, {'pmid': '14518738', 'type': 'RESULT', 'citation': 'Pallikaris lG, Naoumidi TL, Panagopoulou SI, Alegakis AK, Astyrakakis NI. Conductive keratoplasty for low to moderate hyperopia: 1-year results. J Refract Surg. 2003 Sep-Oct;19(5):496-506. doi: 10.3928/1081-597X-20030901-04.'}]}, 'descriptionModule': {'briefSummary': 'Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. It utilizes "blended vision" rather than the true monovision used with laser in situ keratomileusis (LASIK), which patients tolerate more readily. There is very little reported research about the induction of wavefront aberration by CK. The symptomatology of high order aberrations (HOA) and the way individual Zernike functions were correlated with visual acuity, contrast sensitivity, visual symptoms. This study measured the HOA created by surgically induced myopic shift via CK and LASIK in an effort to better understand the phenomena of regression, multifocality, pseudo-accommodation and monovision.', 'detailedDescription': 'To investigate anterior corneal optical higher order aberration (HOA) induced by conductive keratoplasty (CK) and laser in situ keratomileusis (LASIK). 69 eyes with hyperopia or presbyopia were enrolled. 47 eyes of 47 patients underwent CK procedure, 22 eyes underwent LASIK. Data were acquired preoperatively, and at 3 and 6 months postoperatively. The total Root Mean Square (RMS) of the HOA as well as the individual Zernike polynomials of coma, trefoil, and spherical aberration were analyzed. In CK group, the high order RMS showed significant elevation at 3 months, but it returned to near preoperative levels at 6 months postoperatively. Trefoil (Z33) is the exclusive Zenike pattern to increase significantly following CK, peaking at 3 months and then decreasing back to near preoperative level at 6 months after CK. In the hyperopic LASIK group, coma increased to a peak at 3 month postoperatively, and persisted at sixth month after LASIK. Spherical aberration decreased significantly at 3 months and persisted till the sixth postoperative month. There was significant correlation between ΔSE and Δspherical aberration showed in both groups. The HOA and main Zernike polynomials pattern and their natural changes induced by CK is significantly different from that induced by LASIK in the hyperopic corrected treatment. The amount of achieved hyperopic corrections induced by CK or LASIK is not correlated to the change of HOA patterns such as coma and trefoil, but it is correlated to the change of spherical aberration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this consecutive case series, 69 eyes of 57 patients (30 female and 27 male) with hyperopia or presbyopia were enrolled. Inclusion criteria included age of over 40 years old (yrs), stable refraction, and patients who were planned to induce a myopic shift ranging of -1.00 diopters (D) to -2.50D. Mean patient age was 52.9±5.7 yrs (range from 42 to 68 yrs). The ophthalmic examination for each patient included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) (Snellen chart), near vision (Jaeger chart), manifest and cycloplegic refraction, videokeratography, central and peripheral corneal ultrasound pachymetry (thickness), slit-lamp microscopy, dilated fundus examinations, IOP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of over 40 years old (yrs)\n* stable refraction\n* planned to induce a myopic shift\n\nExclusion Criteria:\n\n* age of less than 40 years old (yrs)\n* significant systemic illnesses\n* congenital myopia,\n* media opacity uveitis\n* glaucoma\n* intraocular surgery refractive surgery\n* neurologic diseases\n* retinal disease'}, 'identificationModule': {'nctId': 'NCT04676620', 'briefTitle': 'Comparison of Anterior Corneal Optical Aberration Induced by CK and Hyperopic LASIK', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine'}, 'officialTitle': 'Comparison of Anterior Corneal Optical Aberration Induced by Conductive Keratoplasty and Hyperopic Laser in Situ Keratomileusis', 'orgStudyIdInfo': {'id': '2020-K-107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CK surgery', 'description': 'Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation.', 'interventionNames': ['Procedure: CK surgery']}, {'label': 'LASIK surgery', 'description': 'LASIK surgery is femtosecond laser assisted conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.', 'interventionNames': ['Procedure: CK surgery']}], 'interventions': [{'name': 'CK surgery', 'type': 'PROCEDURE', 'description': 'CK and LASIK are both effective methods for the correction of hypeopia. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.', 'armGroupLabels': ['CK surgery', 'LASIK surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200052', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongxia Wang, director', 'role': 'CONTACT', 'email': 'whxeye@163.com', 'phone': '18302183233', 'phoneExt': '18302183233'}], 'facility': 'Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongxia Wang, director', 'role': 'CONTACT', 'email': 'whxeye@163.com', 'phone': '18302183233'}, {'name': 'Qian Fan, professor', 'role': 'CONTACT', 'email': 'fanqian2002_yahoo@163.com', 'phone': '15022756478'}], 'overallOfficials': [{'name': 'Hongxia Wang, director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wang Hongxia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine', 'investigatorFullName': 'Wang Hongxia', 'investigatorAffiliation': 'Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine'}}}}