Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-31 @ 1:09 AM
Study NCT ID:
NCT05229133
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2021-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UCDVA (with cycloplegia)', 'timeFrame': 'Pre-operative', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA (without cycloplegia)', 'timeFrame': 'Pre-operative', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': 'day 1', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '1 week', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '1 month', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '3 months', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '6 months', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '9 months', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}, {'measure': 'UCDVA', 'timeFrame': '12 months', 'description': 'The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached.\n\nSatisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines.'}], 'secondaryOutcomes': [{'measure': 'Stability of MRSE', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'The percentage of eyes with:\n\n* a change of less than or equal to 1.00 D of MRSE between two refractions\n* a change of less than or equal to 0.50 D of MRSE between two refractions will be reported for the corresponding time period.'}, {'measure': 'Predictability of MRSE', 'timeFrame': 'Up to 12 months', 'description': 'Percentage of eyes achieving MRSE within ± 1.00 D and within ± 0.50 D of the intended outcome at the point at which MRSE stability is achieved.'}, {'measure': 'Efficacy Index', 'timeFrame': 'Up to 12 months', 'description': 'Efficacy Index is defined as UCDVA at the time point, when stability of MRSE is reached, divided by CDVA at baseline:\n\n(UCDVA VX /CDVA V1). Note: "X" corresponds to the visit, when stability of MRSE will have been reached.\n\nThe Efficacy Index being above the efficacy cut-off level 0.8 indicates loss of less than two lines of UCDVA'}, {'measure': 'Stability of MRCYL', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'The stability of the manifest refractive cylinder (MRCYL) will be evaluated for the whole set of eyes treated for astigmatic myopia. The following statistics for the change in the MRCYL between two consecutive post-operative follow-up visits will be recorded:\n\n• percentage of eyes with a change in MRCYL within ±1.0 D and ±0.5 D\n\nStability analyses will be performed on the eyes that had every follow-up exam from 1- month up to the stability time point (the Consistent Cohort), as well as on the eyes that had 2 consecutive post-op exams, but not necessarily every follow-up exam'}, {'measure': 'Predictability of MRCYL', 'timeFrame': 'Up to 12 months', 'description': 'Percentage of eyes achieving MRCYL within ± 1.00 D of the intended outcome, and within ± 0.50 D of the intended outcome at the point at which stability of MRSE is achieved.'}, {'measure': 'Vector analysis (IRC)', 'timeFrame': 'Pre-operative', 'description': 'Intended Refractive Correction Vector (IRC) IRC = Preoperative cylinder - Target (attempted) cylinder'}, {'measure': 'Vector analysis (SIRC)', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'Assessment of change in the Surgically Induced Refractive Correction Vector (SIRC) during follow up; assessed until the MRSE stability is reached.\n\nSIRC = Preoperative cylinder - Postoperative cylinder'}, {'measure': 'Vector analysis (EV)', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'Assessment of change in the Error Vector during follow up; assessed until the MRSE stability is reached.\n\nError Vector (EV) EV = IRC - SIRC'}, {'measure': 'Vector analysis (CR)', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'Assessment of change in the Correction Rate during follow up; assessed until the MRSE stability is reached.\n\nCorrection Ratio (CR) CR = magnitude of SIRC / magnitude of IRC'}, {'measure': 'Vector analysis (ER)', 'timeFrame': 'Assessed at 3 months, 6 months, 9 months and 12 months post surgery.', 'description': 'Assessment of change in the Error Ratio during follow up; assessed until the MRSE stability is reached.\n\nError Ratio (ER) ER = magnitude of EV/ magnitude of IRC'}, {'measure': 'Safety Index', 'timeFrame': 'Up to 12 months', 'description': 'Safety Index defined as CDVA at the time point, when the stability of MRSE is reached, divided by CDVA at baseline (CDVA VX / CDVA V1).'}, {'measure': 'Number of Adverse Events observed in the study', 'timeFrame': 'Up to 12 months.', 'description': 'Complications, including all related (Serious) Adverse Events, during surgery day and follow-up.'}, {'measure': 'Number of Device defects observed in the study', 'timeFrame': 'Up to 12 months', 'description': 'Number of device defects observed during the clinical trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLEAR', 'Ziemer', 'FEMTO LDV', 'Lenticule', 'Myopic astigmatism'], 'conditions': ['Myopic Astigmatism']}, 'descriptionModule': {'briefSummary': 'In this multicenter, prospective, interventional, single-arm clinical trial, the aim is to determine safety and efficacy of CLEAR using the FEMTO LDV Z8 in Chinese patients in China.\n\nThe primary objective is to evaluate the visual outcome after CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia at the time point, when stability of manifest refraction spherical equivalent (MRSE) is reached.\n\nThe corresponding hypothesis is that the percentage of treated eyes with satisfactory Uncorrected Distance Visual Acuity (UCDVA) at the point when stability of MRSE is reached after CLEAR is at least 85% of all treated eyes. This hypothesis has been chosen in line with the recommendations of the "Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers" issued by the FDA.\n\nThe secondary objectives are to evaluate the efficacy and safety with respect to stability, predictability, device defects and adverse events of CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Medically suitable for corneal refractive surgery\n2. Signed informed consent form\n3. Age ≥ 18 years\n4. Pre-operative BCVA ≥ 5.0 (corresponding to 20/20 as per Snellen chart lines)\n5. Myopia sphere from -0.5 D to -10.00 D\n6. Maximum cylinder diopter of -5.00 D\n7. Maximum resulting MRSE of -12.5 D\n8. Calculated residual stromal thickness ≥ 250 microns\n9. Non-contact IOP \\< 21mmHg\n10. Stable refraction for the past year, as demonstrated by a change in manifest refraction spherical equivalent (MRSE) of ≤ 0.50 D\n11. A difference between cycloplegic refraction spherical equivalent and MRSE \\< 0.75 D.\n12. For contact lens wearers (where applicable) after pre-operative stop of contact lens wear: Stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart.\n13. Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator.\n\nExclusion Criteria:\n\n1. Wearing of contact lenses pre-operatively i) soft contact lenses: \\<2 weeks before Visit 1 OR from Visit 1 till the day of surgery ii) hard contact lenses: \\<1 month before Visit 1 OR from Visit 1 till the day of surgery iii) therapeutic contact lenses (such as Ortho-K): \\<3 months before Visit 1 OR from Visit 1 till the day of surgery\n2. Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light\n3. Residual, recurrent, or active ocular disease or corneal abnormality (including, but not limited to ocular herpes zoster or simplex, active infections and inflammation)\n4. History of ocular herpes simplex or herpes zoster keratitis\n5. 3 months before the inclusion have taken systemic medication likely to negatively affect wound healing, such as glucocorticosteroide or antimetabolites\n6. Severe dry eye\n7. Glaucoma\n8. Nystagmus or hemofacial spasm preventing placement of the patient interface\n9. Previous corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes\n10. Unstable central keratometry readings\n11. Mesopic pupil diameter \\> 8.0 mm\n12. Keratometry readings via Sim-K values less than 40.00 D\n13. Allergy to medications required in surgery, pre- and post-operative treatment\n14. Keratoconus or keratectasia, including patients with suspicion of keratoconus on corneal topography\n15. At the time of inclusion, participation in other medical device clinical trials within one month or in drug clinical trials within 3 months\n16. Diagnosis of autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes or AIDS and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study principal investigator\n17. Known psychotic disorders associated with delusions (e.g. schizophrenia)\n18. Woman who is pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT05229133', 'briefTitle': 'Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ziemer Ophthalmic Systems AG'}, 'officialTitle': 'A Multicentre, Prospective, Single-arm Clinical Trial to Evaluate Efficacy and Safety of Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) in Myopia and Astigmatism in Chinese Population', 'orgStudyIdInfo': {'id': 'CPFLM-0008-CN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Refractive correction using CLEAR', 'description': 'Subjects 18+ years old with myopic (-0.50 to -10.00 D) astigmatism (up to -5.00 D) treated bilaterally with FEMTO LDV Z8 using CLEAR application.', 'interventionNames': ['Device: CLEAR']}], 'interventions': [{'name': 'CLEAR', 'type': 'DEVICE', 'otherNames': ['Corneal lenticule extraction for advanced refractive correction'], 'description': 'FEMTO LDV Z8 Surgical Laser is intended for use in Corneal Lenticule Extraction for Advanced Refractive correction (CLEAR), also called Curved Lamellar Resection (CLR), for the reduction or elimination of myopia from -0.50 D to -10.00 D, with astigmatism of 0 D to -5.00 D or without astigmatism, and MRSE of -0.50 D to -12.50 D in the eye to be treated in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.', 'armGroupLabels': ['Refractive correction using CLEAR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changbin Zhai, MD', 'role': 'CONTACT', 'phone': '136 0108 9269'}, {'name': 'Changbin Zhai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Wang, MD', 'role': 'CONTACT', 'phone': '139 0300 2594'}, {'name': 'Zheng Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Aier Eye Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuehua Zhou, MD', 'role': 'CONTACT', 'phone': '139 1083 6019'}, {'name': 'Yuehua Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ineye Hospital of Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi-hao Chen, MD', 'role': 'CONTACT', 'phone': '139 6887 8892'}, {'name': 'Shi-hao Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eye Hospital, WMU', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Olga Grossenbacher, MD, PhD', 'role': 'CONTACT', 'email': 'olga.grossenbacher@ziemergroup.com', 'phone': '+41 79 671 67 25'}], 'overallOfficials': [{'name': 'Shi-hao Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Hospital, WMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziemer Ophthalmic Systems AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tigermed Consulting Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}