Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 2:06 AM
Study NCT ID:
NCT06656403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Artificial Tears on Ocular Biometry Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flat meridian of the anterior corneal surface (K1)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'K1 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'steep meridian of the anterior corneal surface (K2)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'K2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'central corneal thickness (CCT)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'CCT was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}], 'secondaryOutcomes': [{'measure': 'axial length (AL)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'AL was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'corneal curvature radius(R1,R2)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'R1,R2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'anterior chamber depth (ACD)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'ACD was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'white-to-white corneal diameter (WTW)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'WTW was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'Pupil (Pup)', 'timeFrame': 'Baseline,30s,2min,5min', 'description': 'Pup was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)'}, {'measure': 'non-invasive tear break-up time (NITBUT)', 'timeFrame': 'Baseline', 'description': 'Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded'}, {'measure': 'tear meniscus height(TMH)', 'timeFrame': 'Baseline', 'description': 'TMH using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded'}, {'measure': 'ocular surface disease index(OSDI)', 'timeFrame': 'Baseline', 'description': 'Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dry eye', 'IOL Master 700', 'tear film'], 'conditions': ['Dry Eye Disease', 'Tear Film']}, 'referencesModule': {'references': [{'pmid': '32828877', 'type': 'BACKGROUND', 'citation': 'Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.'}, {'pmid': '35989638', 'type': 'BACKGROUND', 'citation': 'Nibandhe AS, Donthineni PR. Understanding and Optimizing Ocular Biometry for Cataract Surgery in Dry Eye Disease: A Review. Semin Ophthalmol. 2023 Jan;38(1):24-30. doi: 10.1080/08820538.2022.2112699. Epub 2022 Aug 20.'}, {'pmid': '26948792', 'type': 'BACKGROUND', 'citation': 'Chen X, Yuan F, Wu L. Metaanalysis of intraocular lens power calculation after laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2016 Jan;42(1):163-70. doi: 10.1016/j.jcrs.2015.12.005.'}, {'pmid': '30481804', 'type': 'BACKGROUND', 'citation': 'Koh S. Irregular Astigmatism and Higher-Order Aberrations in Eyes With Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES36-DES40. doi: 10.1167/iovs.17-23500.'}, {'pmid': '29907632', 'type': 'BACKGROUND', 'citation': 'Koh S, Tung CI, Inoue Y, Jhanji V. Effects of tear film dynamics on quality of vision. Br J Ophthalmol. 2018 Dec;102(12):1615-1620. doi: 10.1136/bjophthalmol-2018-312333. Epub 2018 Jun 15.'}, {'pmid': '26432124', 'type': 'BACKGROUND', 'citation': 'Epitropoulos AT, Matossian C, Berdy GJ, Malhotra RP, Potvin R. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. J Cataract Refract Surg. 2015 Aug;41(8):1672-7. doi: 10.1016/j.jcrs.2015.01.016.'}, {'pmid': '24310239', 'type': 'BACKGROUND', 'citation': 'Sheard R. Optimising biometry for best outcomes in cataract surgery. Eye (Lond). 2014 Feb;28(2):118-25. doi: 10.1038/eye.2013.248. Epub 2013 Dec 6.'}, {'pmid': '32982163', 'type': 'BACKGROUND', 'citation': 'Hovanesian J, Epitropoulos A, Donnenfeld ED, Holladay JT. The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery. Clin Ophthalmol. 2020 Sep 16;14:2709-2716. doi: 10.2147/OPTH.S264520. eCollection 2020.'}, {'pmid': '22081032', 'type': 'BACKGROUND', 'citation': 'Sahin A, Hamrah P. Clinically relevant biometry. Curr Opin Ophthalmol. 2012 Jan;23(1):47-53. doi: 10.1097/ICU.0b013e32834cd63e.'}]}, 'descriptionModule': {'briefSummary': 'Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.', 'detailedDescription': "Over the past ten years, surgery has progressed from rejuvenation surgery to refractive surgery, which focuses on enhancing both vision and addressing pre-existing issues that impact visual quality. This is why good surgical outcomes involve thorough preoperative assessment and precise intraocular lens(IOL) power determination. To achieve the intended postoperative refractive outcomes, it is essential to perform an accurate calculation of intraocular lens power (i.e., biometry), which may impact the accuracy of the computation.\n\nDamage to the eye's surface from chronic inflammation and induced tear film hyperosmolarity occurs in DED because tear film homeostasis is disrupted. The changes in tear film dynamics and damage to the ocular surface result in mistakes in optical measures, which in turn affect the results of procedures like cataract surgery that heavily rely on these assessments.\n\nConsequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n(1) age ≥18 years,(2) able and willing to comply with the treatment schedule.\n\nExclusion Criteria:\n\n1. The eyes cannot fixate on the fixation lamp (such as children, nystagmus diseases, severe low vision, inattention, etc.) and cannot act according to the user's instructions and sit in the front of the equipment (the forehead or lower song is injured so that it cannot be supported on the forehead / lower song bracket)\n2. The eyes are cloudy with optical media (such as corneal opacity, central corneal scar, mature cataract, posterior chamber bag opacity, vitreous hemorrhage, etc.).\n3. The eyelid is completely closed or too small (drooping, relaxation) resulting in complete or partial occlusion of the cornea\n4. Just after contact measurement or examination, use a corneal local anesthesia solution. (IOL Master 700 should avoid using local anesthetic before all contact examinations)\n5. Tear film deformation (lack of specular reflection of the cornea during corneal curvature measurement), the severity of grade IV dry eye, and whether eye drops were used 24 hours before the examination.\n6. Any corneal lesions (corneal irregularity, corneal scar or corrosive burning, severe irregular astigmatism of cornea)\n7. Fundus lesions (changes in the anatomical morphology of retinal macular fovea during axial length measurement, such as retinal detachment, edema, ulcer, etc.)\n8. Patients with ocular trauma, surgery, and excessive photosensitivity, such as photodynamic therapy (PDT), were excluded.\n9. using eye drops (0.1% Sodium hyaluronate) allergic patients"}, 'identificationModule': {'nctId': 'NCT06656403', 'briefTitle': 'Effect of Artificial Tears on Ocular Biometry Parameters', 'organization': {'class': 'OTHER', 'fullName': 'He Eye Hospital'}, 'officialTitle': 'Effect of Artificial Tears on Ocular Biometry Parameters', 'orgStudyIdInfo': {'id': 'IOL2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study group', 'description': 'dry eye patients', 'interventionNames': ['Drug: 0.1% sodium hyaluronate']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'non-dry eye patients', 'interventionNames': ['Drug: 0.1% sodium hyaluronate']}], 'interventions': [{'name': '0.1% sodium hyaluronate', 'type': 'DRUG', 'description': 'After baseline measurement, 0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guanghao Qin', 'role': 'CONTACT', 'email': 'qinguanghao2020@163.com', 'phone': '+86-18842664420'}], 'overallOfficials': [{'name': 'Guanghao Qin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'He Eye Specialist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}