Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06966167
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-03', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in central corneal endothelial cell density (ECD) from baseline to postoperative time points', 'timeFrame': 'From enrollment to the end of treatment at 2years'}, {'measure': 'Change in corneal thickness from baseline to postoperative time points', 'timeFrame': 'From enrollment to the end of treatment at 2years'}], 'secondaryOutcomes': [{'measure': 'Change in corneal densitometry (central, superior, inferior, nasal, temporal zones)', 'timeFrame': 'From enrollment to the end of treatment at 2years'}, {'measure': 'Postoperative visual acuity outcomes (UDVA, CDVA)', 'timeFrame': 'From enrollment to the end of treatment at 2years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fuchs Endothelial Corneal Dystrophy', 'Cataract', 'Femtosecond Laser-Assisted Cataract Surgery', 'Conventional Phacoemulsification Surgery'], 'conditions': ['Fuchs Endothelial Corneal Dystrophy', 'Cataract']}, 'referencesModule': {'references': [{'pmid': '39320570', 'type': 'BACKGROUND', 'citation': 'Lupardi E, Moramarco A, Cassini F, Febbraro S, Savini G, Fontana L. Corneal densitometry measurements comparison between anterior segment OCT and scheimpflug imaging. Int Ophthalmol. 2024 Sep 25;44(1):392. doi: 10.1007/s10792-024-03309-0.'}, {'pmid': '35462618', 'type': 'BACKGROUND', 'citation': 'Aiello F, Gallo Afflitto G, Ceccarelli F, Cesareo M, Nucci C. Global Prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in Adult Population: A Systematic Review and Meta-Analysis. J Ophthalmol. 2022 Apr 14;2022:3091695. doi: 10.1155/2022/3091695. eCollection 2022.'}, {'pmid': '36637659', 'type': 'BACKGROUND', 'citation': 'Ali M, Cho K, Srikumaran D. Fuchs Dystrophy and Cataract: Diagnosis, Evaluation and Treatment. Ophthalmol Ther. 2023 Apr;12(2):691-704. doi: 10.1007/s40123-022-00637-1. Epub 2023 Jan 13.'}, {'pmid': '9071233', 'type': 'BACKGROUND', 'citation': 'Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to compare the mid- to long-term efficacy of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) in patients with moderate to severe Fuchs' endothelial corneal dystrophy (FECD) complicated by cataracts.\n\nThe main questions it aims to answer are:\n\nDoes FLACS lead to better preservation of corneal endothelial cells compared to CPS in patients with moderate to severe FECD? How do visual outcomes and corneal transparency compare between FLACS and CPS in this patient population?\n\nComparison Group:\n\nResearchers will compare patients undergoing FLACS with those undergoing CPS to evaluate differences in endothelial cell loss, corneal thickness, visual acuity, and corneal transparency.\n\nParticipants:\n\nAdults aged 40 years and older diagnosed with moderate to severe FECD (endothelial cell density \\<1500 cells/mm²).\n\nPatients scheduled for cataract surgery at participating centers.\n\nParticipants will undergo:\n\nPreoperative evaluations, including visual acuity tests, corneal endothelial cell density assessment (central and five peripheral zones), corneal thickness, and corneal densitometry.\n\nSurgical intervention with either FLACS or CPS. Postoperative follow-ups at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, including assessments of endothelial cell density, visual acuity, and corneal thickness.\n\nThis study aims to provide evidence-based recommendations for optimizing surgical strategies in high-risk patients with FECD and cataracts.", 'detailedDescription': "Fuchs' endothelial corneal dystrophy (FECD) is a progressive, bilateral corneal disorder characterized by endothelial cell loss, Descemet's membrane thickening, and corneal edema, leading to visual impairment. Patients with moderate to severe FECD are particularly vulnerable to corneal decompensation following cataract surgery due to their compromised endothelial function. As cataract surgery is a common necessity in this patient population, selecting an appropriate surgical technique that minimizes endothelial cell damage is crucial to ensuring optimal postoperative outcomes.\n\nThis observational, prospective, multi-center controlled study aims to compare the mid- to long-term efficacy and safety of femtosecond laser-assisted cataract surgery (FLACS) versus conventional phacoemulsification surgery (CPS) in patients with moderate to severe FECD undergoing cataract extraction. The study seeks to determine which technique better preserves corneal endothelial integrity and maintains visual function, providing valuable insights into surgical decision-making for this high-risk patient population.\n\nStudy Objectives The primary objective of this study is to evaluate the differences in corneal endothelial cell density (ECD) loss and corneal thickness changes between FLACS and CPS in patients with moderate to severe FECD undergoing cataract surgery.\n\nThe secondary objectives include:\n\nAssessing differences in postoperative visual acuity, including uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA).\n\nComparing corneal densitometry and transparency changes between the two surgical techniques.\n\nEvaluating postoperative corneal edema and potential complications related to endothelial decompensation.\n\nStudy Design Type: Prospective, observational, multi-center, controlled study Study Sites: Three ophthalmology centers with similar surgical and imaging equipment Participants: 120 eyes from 120 patients (FLACS group: 80 eyes; CPS group: 40 eyes)\n\nGrouping: Patients will be assigned to either FLACS or CPS based on clinical indications rather than randomization. Subgroup analyses will be conducted based on:\n\nAge (\\>70 years vs. ≤70 years) Preoperative endothelial cell density (\\<1000 cells/mm² vs. ≥1000 cells/mm²) Cataract nuclear grading (\\>grade 3 vs. ≤grade 3) Eligibility Criteria\n\nInclusion Criteria:\n\nPatients scheduled for cataract surgery Age ≥40 years Diagnosed with moderate to severe FECD (endothelial cell density \\<1500 cells/mm²)\n\nExclusion Criteria:\n\nHistory of prior intraocular surgery Presence of ocular conditions other than FECD and cataracts (e.g., severe dry eye, corneal scarring, keratoconus, uveitis, uncontrolled glaucoma, vitreoretinal disease) Requirement for additional intraocular procedures during the study period (excluding Nd:YAG posterior capsulotomy)\n\nDiscontinuation Criteria:\n\nFailure to complete scheduled follow-up visits Serious adverse events (e.g., vision-threatening endophthalmitis) Participant withdrawal from the study Interventions \\& Assessments\n\nPreoperative Evaluation:\n\nComprehensive ophthalmic examination, including visual acuity testing (UDVA, CDVA), intraocular pressure (IOP), and refraction Biometric assessment using IOLMaster Corneal endothelial cell density measurement using specular microscopy and confocal microscopy (central, superior, inferior, nasal, and temporal zones) Corneal pachymetry and densitometry evaluation using Pentacam\n\nSurgical Interventions:\n\nFLACS Group: Patients will undergo femtosecond laser-assisted cataract surgery, which includes laser-assisted corneal incisions, capsulotomy, and lens fragmentation, followed by phacoemulsification.\n\nCPS Group: Patients will undergo conventional phacoemulsification with manual capsulorhexis and lens nucleus fragmentation using ultrasound energy.\n\nPostoperative Follow-Up Schedule:\n\nPatients will be followed up at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years postoperatively. At each follow-up visit, the following assessments will be performed:\n\nVisual acuity (UDVA, CDVA) Intraocular pressure measurement Corneal endothelial assessment using specular and confocal microscopy Corneal pachymetry and densitometry using Pentacam Outcome Measures\n\nPrimary Outcomes:\n\nChange in central corneal endothelial cell density (ECD) from baseline to postoperative time points Change in corneal thickness from baseline to postoperative time points\n\nSecondary Outcomes:\n\nChange in corneal densitometry (central, superior, inferior, nasal, temporal zones) Postoperative visual acuity outcomes (UDVA, CDVA) Rate of corneal edema and decompensation Incidence of surgical complications (e.g., intraoperative endothelial damage, postoperative corneal haze) Statistical Analysis Continuous variables will be expressed as mean ± standard deviation (SD) and analyzed using t-tests or ANOVA.\n\nCategorical variables will be analyzed using Chi-square tests. Non-normally distributed data will be evaluated using the Mann-Whitney U test. Longitudinal changes will be assessed using repeated-measures ANOVA or Friedman's test.\n\nPearson correlation analysis will be used to evaluate relationships between variables.\n\nA p-value \\< 0.05 will be considered statistically significant.\n\nEthical Considerations This study will be conducted in compliance with the Declaration of Helsinki and national ethical guidelines. Informed consent will be obtained from all participants prior to enrollment. Patient confidentiality will be maintained through anonymized data collection and storage. The study protocol has been reviewed and approved by the institutional ethics committee.\n\nSignificance of the Study This study will provide critical evidence on the optimal surgical approach for cataract patients with FECD, guiding clinicians in making evidence-based surgical decisions to improve visual outcomes and reduce endothelial cell loss in this vulnerable population. It may also contribute to refining surgical techniques and identifying best practices for preserving corneal endothelial health during cataract surgery in patients with pre-existing endothelial dysfunction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants aged 40 years or older, diagnosed with moderate to severe Fuchs endothelial corneal dystrophy (endothelial cell density \\< 1500 cells/mm²), and presenting with visually significant cataract.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for cataract surgery\n* Age ≥40 years\n* Diagnosed with moderate to severe FECD (endothelial cell density \\<1500 cells/mm²)\n\nExclusion Criteria:\n\n* History of prior intraocular surgery\n* Presence of ocular conditions other than FECD and cataracts (e.g., severe dry eye, corneal scarring, keratoconus, uveitis, uncontrolled glaucoma, vitreoretinal disease)\n* Requirement for additional intraocular procedures during the study period (excluding Nd:YAG posterior capsulotomy)'}, 'identificationModule': {'nctId': 'NCT06966167', 'briefTitle': 'Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts', 'orgStudyIdInfo': {'id': 'Fuchs FLACS vs CPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'conventional phacoemulsification surgery (CPS)'}, {'label': 'femtosecond laser-assisted cataract surgery (FLACS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': '1532483480@qq.com', 'phone': '15088920668'}], 'facility': 'Eye and ENT hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jin Yang', 'role': 'CONTACT', 'email': 'jin_er76@hotmail.com', 'phone': '+86 021-64377134'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Jin Yang', 'investigatorAffiliation': 'Eye & ENT Hospital of Fudan University'}}}}