Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-09 @ 2:43 PM
Study NCT ID:
NCT06484894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To find if there a correlation between refractive errors and the central corneal thickness', 'timeFrame': 'Baseline', 'description': 'Study the effect of refractive errors on central corneal thickness'}], 'secondaryOutcomes': [{'measure': 'To study if there a difference between measurement by pentacam and measurement of IOL master', 'timeFrame': 'Baseline', 'description': 'Study which device is more accurate in measuring the central corneal thickness and if there is any difference between the two devices'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Corneal Thickness']}, 'referencesModule': {'references': [{'pmid': '27757993', 'type': 'BACKGROUND', 'citation': 'Wang Q, Liu W, Wu Y, Ma Y, Zhao G. Central corneal thickness and its relationship to ocular parameters in young adult myopic eyes. Clin Exp Optom. 2017 May;100(3):250-254. doi: 10.1111/cxo.12485. Epub 2016 Oct 18.'}, {'pmid': '21107245', 'type': 'BACKGROUND', 'citation': 'Prasad A, Fry K, Hersh PS. Relationship of age and refraction to central corneal thickness. Cornea. 2011 May;30(5):553-5. doi: 10.1097/ICO.0b013e3181fb880c.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of refractive errors on the central corneal thickness obtained by Pentacam and intraocular lenses (IOL) master in eyes with different refractive errors.', 'detailedDescription': 'Central corneal thickness (CCT) is a key indicator of corneal health status and helps to assess corneal diseases. The normal corneal thickness is about 540 μm and mainly consists of the stroma, which is estimated at 450 μm in the center. The stroma provides vital structural integrity and plays a key role in helping maintain transparency. It has been reported, however, that CCT follows a diurnal pattern being 10 μm thicker in the morning due to reduced evaporation of water from underneath the closed eyelids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Inclusion criteria:\n\n Subjects included in this study aged between20 and 41 asked for refractive surgery\n2. Exclusion criteria:-\n\n * Severe corneal scarrig or opacification., dystrophy\n * Patients with history of recent contact lens Ocular trauma.\n * Uveitis patients Patients with keratoconus.\n * Previous ocular or refractive surgey', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects included in this study aged between20 and 41 years, asked for refractive surgery\n\nExclusion Criteria:\n\n* patients with corneal scarrig or opacification.\n\n * Patients with corneal dystrophies.\n * Patients with keratoconus.\n * Previous ocular or refractive surgery.\n * Ocular trauma.\n * Uveitis patients.\n * Patients with history of recent contact lens wear.'}, 'identificationModule': {'nctId': 'NCT06484894', 'briefTitle': 'The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam', 'orgStudyIdInfo': {'id': 'Central corneal thickness'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypermetrope', 'description': 'Effect of hypermetropia on central corneal thickness by using pentacam and IOL master', 'interventionNames': ['Device: Pentacam and IOL master']}, {'label': 'Emmetrope', 'description': 'Effect of emmetropia on central corneal thickness by using pentacam and IOL master', 'interventionNames': ['Device: Pentacam and IOL master']}, {'label': 'Myopia', 'description': 'Effect of myopia on central corneal thickness by using pentacam and IOL master', 'interventionNames': ['Device: Pentacam and IOL master']}], 'interventions': [{'name': 'Pentacam and IOL master', 'type': 'DEVICE', 'description': 'Device used for measurement of central corneal thickness', 'armGroupLabels': ['Emmetrope', 'Hypermetrope', 'Myopia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Haidy Nayer Adly, Master', 'role': 'CONTACT', 'email': 'Haidynayer4@gmail.com', 'phone': '01277603313'}], 'overallOfficials': [{'name': 'Mahmoud Fathy rateb, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Ahmed Abd el Nasser awad, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Mohamed Tarek Abd el menaam, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Haidy Nayer Adly', 'investigatorAffiliation': 'Assiut University'}}}}