Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:24 AM
Study NCT ID:
NCT07446751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of SMILE PRO for High Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 113}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Refractive Astigmatism', 'timeFrame': '12 months postoperatively', 'description': 'Residual refractive astigmatism was measured using manifest refraction and analyzed with astigmatic vector analysis based on the Alpins method.'}, {'measure': 'Refractive Accuracy (Spherical Equivalent Error)', 'timeFrame': '12 months postoperatively', 'description': 'Refractive accuracy was assessed using manifest refraction spherical equivalent (SEQ) after SMILE PRO surgery.'}], 'secondaryOutcomes': [{'measure': 'Refractive Stability Over Time (Spherical Equivalent)', 'timeFrame': '1 week, 1 month, 3 months, 6 months, and 12 months postoperatively', 'description': 'Manifest refraction spherical equivalent (SEQ) was measured at each postoperative visit to evaluate refractive stability.'}, {'measure': 'Refractive Cylinder Over Time', 'timeFrame': '1 week, 1 month, 3 months, 6 months, and 12 months postoperatively', 'description': 'Manifest refractive cylinder was measured using subjective refraction and expressed in diopters (D) at scheduled postoperative visits following SMILE Pro surgery. This outcome evaluates the magnitude and stability of residual astigmatism during the 12-month follow-up period.'}, {'measure': 'Uncorrected Distance Visual Acuity (UDVA)', 'timeFrame': '1 week, 1 month, 3 months, 6 months, and 12 months postoperatively', 'description': 'Uncorrected distance visual acuity was measured using standardized logMAR charts.'}, {'measure': 'Corrected Distance Visual Acuity (CDVA)', 'timeFrame': '1 month, 3 months, 6 months, and 12 months postoperatively', 'description': 'Corrected distance visual acuity was assessed to evaluate visual safety after surgery.'}, {'measure': 'Surgically Induced Astigmatism (SIA)', 'timeFrame': '3 months and 12 months postoperatively', 'description': 'Surgically induced astigmatism, expressed in diopters (D), represents the vector magnitude of astigmatic change produced by surgery. It was calculated using the Alpins vector analysis method by comparing preoperative and postoperative refractive cylinder magnitude and axis.'}, {'measure': 'Target Induced Astigmatism (TIA)', 'timeFrame': '3 months and 12 months postoperatively', 'description': 'Target induced astigmatism, expressed in diopters (D), represents the vector magnitude of astigmatic correction intended by the surgical plan. It was calculated using the Alpins vector analysis method based on the preoperative refractive cylinder magnitude and the planned axis of correction.'}, {'measure': 'Difference Vector (DV)', 'timeFrame': '3 months and 12 months postoperatively', 'description': 'Difference vector (DV), expressed in diopters (D), represents the vector magnitude of residual astigmatism that would need to be corrected to achieve the intended target. It was calculated using the Alpins vector analysis method based on postoperative refractive cylinder magnitude and axis relative to the planned correction.'}, {'measure': 'Correction Index (CI)', 'timeFrame': '3 months and 12 months postoperatively', 'description': 'Correction index, expressed as a unitless ratio, represents the ratio of surgically induced astigmatism to target induced astigmatism. It was calculated using the Alpins vector analysis method to quantify the accuracy of astigmatic correction. A value of 1.0 indicates exact correction, values greater than 1.0 indicate overcorrection, and values less than 1.0 indicate undercorrection.'}, {'measure': 'Angle of Error (AE)', 'timeFrame': '3 months and 12 months postoperatively', 'description': 'Angle of error, expressed in degrees (°), represents the angular difference between the achieved astigmatic correction and the intended target axis. It was calculated using the Alpins vector analysis method based on the deviation between the axis of surgically induced astigmatism and the planned treatment axis. Positive and negative values indicate counterclockwise and clockwise deviations from the intended axis, respectively.'}, {'measure': 'Higher-Order Aberrations', 'timeFrame': '1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.', 'description': 'Ocular higher-order aberrations were measured using wavefront aberrometry to assess postoperative visual quality.'}, {'measure': 'Contrast Sensitivity', 'timeFrame': '1 week, 1 month, 3 months, 6 months, and 12 months postoperatively', 'description': 'Contrast sensitivity was evaluated under photopic conditions to assess functional visual quality.'}, {'measure': 'Lenticule Decentration', 'timeFrame': 'Intraoperative', 'description': 'Lenticule decentration is defined as the linear displacement between the intended lenticule center and the corneal vertex during SMILE PRO surgery. This parameter is automatically recorded intraoperatively by the CentraLign software integrated into the VisuMax 800 femtosecond laser system, based on real-time centration alignment guidance. Decentration is quantified as a continuous variable and expressed in millimeters (mm). For descriptive analysis, decentration values are categorized as \\< 0.1 mm, 0.1-0.19 mm, and ≥ 0.2 mm. For regression analyses, the continuous decentration value (mm) is used.'}, {'measure': 'Intraoperative Cyclotorsion', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative cyclotorsion is defined as the rotational misalignment (in degrees) between the preoperative reference axis obtained from iris registration and the intraoperative axis detected during docking using the OcuLign and CentraLign systems integrated into the VisuMax 800 platform. Cyclotorsion is recorded automatically by the system in degrees (°). Negative values indicate clockwise rotation and positive values indicate counterclockwise rotation. The magnitude of cyclotorsion is analyzed in relation to postoperative refractive outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SMILE PRO', 'High astigmatism', 'Small incision lenticule extraction', 'Astigmatic vector analysis', 'Cyclotorsion', 'Higher-order aberrations', 'Contrast sensitivity'], 'conditions': ['High Astigmatism']}, 'referencesModule': {'references': [{'pmid': '37162399', 'type': 'BACKGROUND', 'citation': 'Reinstein DZ, Archer TJ, Potter JG, Gupta R, Wiltfang R. Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800. J Refract Surg. 2023 May;39(5):294-301. doi: 10.3928/1081597X-20230301-02. Epub 2023 May 1.'}, {'pmid': '28068441', 'type': 'BACKGROUND', 'citation': 'Pedersen IB, Ivarsen A, Hjortdal J. Changes in Astigmatism, Densitometry, and Aberrations After SMILE for Low to High Myopic Astigmatism: A 12-Month Prospective Study. J Refract Surg. 2017 Jan 1;33(1):11-17. doi: 10.3928/1081597X-20161006-04.'}, {'pmid': '29909252', 'type': 'BACKGROUND', 'citation': 'Chan TCY, Wang Y, Ng ALK, Zhang J, Yu MCY, Jhanji V, Cheng GPM. Vector analysis of high (>/=3 diopters) astigmatism correction using small-incision lenticule extraction and laser in situ keratomileusis. J Cataract Refract Surg. 2018 Jul;44(7):802-810. doi: 10.1016/j.jcrs.2018.04.038. Epub 2018 Jun 13.'}, {'pmid': '35382779', 'type': 'BACKGROUND', 'citation': 'Zhou J, Gu W, Gao Y, He G, Zhang F. Vector analysis of high astigmatism (>/= 2.0 diopters) correction after small-incision lenticule extraction with stringent head positioning and femtosecond laser-assisted laser in situ keratomileusis with compensation of cyclotorsion. BMC Ophthalmol. 2022 Apr 5;22(1):157. doi: 10.1186/s12886-022-02384-0.'}]}, 'descriptionModule': {'briefSummary': 'This prospective interventional study aims to evaluate the long-term refractive and visual quality outcomes of SMILE PRO surgery in patients with myopia and high astigmatism. Eligible participants undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser. Postoperative assessments include uncorrected and corrected distance visual acuity, manifest refraction, astigmatic vector analysis, contrast sensitivity, and higher-order aberrations. Participants are followed for up to 12 months to assess refractive accuracy, stability, safety, and visual quality after surgery.', 'detailedDescription': 'This is a single-center, prospective interventional clinical study conducted to assess the long-term refractive and visual quality outcomes of SMILE PRO surgery for the correction of myopia with high astigmatism. The study is performed at Hong Son Eye Hospital, Vietnam, following approval from the Institutional Review Board of Hanoi Medical University. All participants provide written informed consent prior to enrollment.\n\nPatients aged 18 to 40 years with stable myopic refractive error and high astigmatism are eligible for inclusion. All eyes undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser according to a standardized surgical protocol. Manifest refraction, corneal topography, and ocular imaging are performed by experienced refractive technicians using standardized measurement protocols. All patients are examined preoperatively and postoperatively by an ophthalmologist, who reviews clinical findings and surgical eligibility. All SMILE PRO procedures are performed by the same ophthalmic surgeon to minimize variability related to surgical technique.\n\nOutcome measures include uncorrected and corrected distance visual acuity, spherical equivalent refraction, residual refractive astigmatism, and astigmatic vector analysis based on the Alpins method. Visual quality outcomes are further evaluated using contrast sensitivity testing and wavefront aberrometry to assess higher-order aberrations. Intraoperative parameters, including centration and cyclotorsion, are recorded and analyzed for their potential association with postoperative refractive outcomes.\n\nPostoperative examinations are performed at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. The primary objective of this study is to evaluate the long-term refractive accuracy, stability, and safety of SMILE PRO surgery in eyes with high astigmatism. Secondary objectives include the assessment of preoperative and intraoperative factors influencing postoperative visual and refractive outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 40 years at the time of surgery\n* Diagnosis of myopia with high astigmatism eligible for SMILE PRO surgery\n* Stable refractive error prior to surgery\n* Adequate corneal thickness and topographic parameters suitable for SMILE PRO\n* Ability to understand the study procedures and provide written informed consent\n* Willingness and ability to attend scheduled postoperative follow-up visits\n\nExclusion Criteria:\n\n* Presence of corneal ectatic disorders or suspicious corneal topography\n* History of previous ocular surgery or ocular trauma\n* Active ocular disease other than refractive error\n* Systemic diseases known to affect wound healing\n* Pregnancy or breastfeeding at the time of surgery'}, 'identificationModule': {'nctId': 'NCT07446751', 'briefTitle': 'Long-term Outcomes of SMILE PRO for High Astigmatism', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': 'Outcomes of SMILE PRO Surgery for the Correction of Myopia With High Astigmatism', 'orgStudyIdInfo': {'id': '#HMUIRB1649#'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMILE PRO surgery', 'description': 'Participants with myopia and high astigmatism undergoing small incision lenticule extraction using the SMILE PRO surgery.', 'interventionNames': ['Procedure: SMILE PRO surgery']}], 'interventions': [{'name': 'SMILE PRO surgery', 'type': 'PROCEDURE', 'description': 'Small incision lenticule extraction surgery performed using the VisuMax 800 femtosecond laser (SMILE PRO) for the correction of myopia with high astigmatism. The procedure is performed by a single experienced ophthalmic surgeon following a standardized surgical protocol.', 'armGroupLabels': ['SMILE PRO surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Hong Son Eye Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Lan Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanoi Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available beginning 12 months after publication of the primary results and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data underlying the results reported in this study will be made available. Shared data will include demographic characteristics, preoperative and postoperative refractive outcomes, visual acuity measurements, astigmatic vector parameters, contrast sensitivity results, and wavefront-derived higher-order aberrations. No personally identifiable information will be shared.', 'accessCriteria': 'Data will be shared with qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators, and data access will be granted after approval of the proposal and signing of a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}