Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-04-10 @ 1:11 AM
Study NCT ID:
NCT06555367
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scleral lens fitting assessment', 'timeFrame': '4 hours later', 'description': 'The fitting assessment is conducted using a slit lamp microscope to observe the central positioning of the lens, the tear film space under the lens, and the vascular compression on the peripheral conjunctival surface. OCT is applied to measure the tear film space between the central and peripheral non-contact areas of the lens and the anterior corneal surface, as well as the landing zone of the lens in all peripheral directions.'}], 'secondaryOutcomes': [{'measure': 'Subjective comfort assessment', 'timeFrame': '4 hours later', 'description': 'Level 1: Very uncomfortable; Level 2: Uncomfortable; Level 3: Moderate comfort; Level 4: Comfortable; Level 5: Very comfortable.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. This prospective clinical study enrolled patients diagnosed with OSD-related irregular corneal astigmatism. Participants underwent comprehensive ophthalmic evaluation, including corneal topography, visual acuity assessment, and tear film analysis. Qualified subjects were fitted with scleral lenses and followed up at intervals of one week, one month, and three months post-fitting. The primary outcomes measured were uncorrected and corrected visual acuity, comfort levels assessed via a standardized questionnaire, and fitting success rates. Data were analyzed using appropriate statistical methods to compare pre- and post-intervention values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with irregular corneal astigmatism who visited the ophthalmology clinic of the Second Affiliated Hospital of Zhejiang University for scleral lens fitting from January 2022 to June 2024 were selected. This includes patients with post-keratoconus cross-linking surgery, post-keratoplasty, and those with corneal irregularities caused by trauma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with irregular corneal astigmatism, including those with post-keratoconus cross-linking surgery, post-keratoplasty, and corneal irregularities caused by trauma; Volunteers who are willing to participate in this trial, have signed the informed consent form, and are willing to cooperate with the treatment and follow-up; Individuals aged 18 years or older (including 18 years old), with no gender restrictions; Cases collected from January 2023 to August 2024.\n\nExclusion Criteria:\n\n* Unable or unwilling to sign the consent form, or unable to follow the study procedures; Nursing or pregnant women; Individuals with acute ocular inflammation or infection; Corneal endothelium: Cell Density (CD) \\<1000/mm²; Individuals required to wear lenses overnight; Poor compliance; Those who do not meet the hygiene requirements for lens wear; Individuals whom the investigator deems have other reasons making them unsuitable for the trial.'}, 'identificationModule': {'nctId': 'NCT06555367', 'briefTitle': 'Clinical Application Research of Scleral Lenses in Ocular Surface Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Application Research of Scleral Lenses in Ocular Surface Diseases', 'orgStudyIdInfo': {'id': '2024-0667'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'scleral lenses group', 'description': 'The case group consists of patients with irregular corneas who wear scleral lenses.', 'interventionNames': ['Device: scleral lenses']}, {'label': 'control group', 'description': 'The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses.'}], 'interventions': [{'name': 'scleral lenses', 'type': 'DEVICE', 'description': 'Wear scleral lenses', 'armGroupLabels': ['scleral lenses group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'rui yi zhu', 'role': 'CONTACT', 'email': 'zhuyirui001@126.com', 'phone': '15868805518'}, {'name': 'lin lin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital of Zhejiang University Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'ming xiu jin', 'role': 'CONTACT', 'email': '18344980412@qq.com', 'phone': '13989455778'}, {'name': 'rui yi zhu', 'role': 'CONTACT', 'email': 'zhuyirui001@126.com', 'phone': '15868805518'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}