Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-10 @ 5:33 PM
Study NCT ID:
NCT03633851
Status:
UNKNOWN
Last Update Posted:
2018-08-16
First Post:
2018-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toric IOL vs Non-toric IOL With LRI for Corneal Astigmatism
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.', 'timeFrame': '6 months and 12 months', 'description': 'Astigmatism reduction will be evaluated with optical biometry, corneal topography'}, {'measure': 'Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL', 'timeFrame': '6 months and 12 months', 'description': 'Astigmatism reduction will be evaluated with manifest refraction, autorefraction'}], 'secondaryOutcomes': [{'measure': 'Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.', 'timeFrame': '6 months and 12 months', 'description': 'Measurement of uncorrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m. Although these assessments appear to have different units of measurements, but all the measurements will be in the same units of measure.'}, {'measure': 'Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.', 'timeFrame': '6 months and 12 months', 'description': 'Measurement of best-spectacle corrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m.'}, {'measure': 'Quality of Vision', 'timeFrame': '6 months and 12 months', 'description': 'Quality of Vision will be evaluated with the QoV (Quality of Vision) questionnaire score. It is a validated, Rasch-adjusted questionnaire in which patients are asked to rate 10 dysphotopsia items illustrated by standard photographs, scoring each item (0, 1, 2, 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total).'}, {'measure': 'Visual disability', 'timeFrame': '6 months and 12 months', 'description': 'Visual disability will be evaluated with the Catquest 9-SF cataract visual disability questionnaire. It is a Rasch-adjusted cataract visual disability questionnaire that asks patients to rate difficulty with a range of vision-related daily activities.'}, {'measure': 'Overall satisfaction', 'timeFrame': '6 months and 12 months', 'description': 'Overall satisfaction will be evaluated with vision rating questionnaire. It will be obtained by asking patients to rate whether they were very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, or very unsatisfied.'}, {'measure': 'Dysphotopsia', 'timeFrame': '6 months and 12 months', 'description': 'Dysphotopsia will be evaluated with the Dysphotopsia questionnaire. They are 4 questions regarding dysphotopsia symptoms: "Since your surgery, have you noticed any" halo, glare or dazzle, unwanted images, or shadows? Patients were asked to respond by indicating whether they had not experienced these symptoms at all ("none") or found them "barely noticeable," "annoying," or "debilitating."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to compare the astigmatism reducing effect of a toric intraocular lens (IOL) (model MX60T - Bausch \\& Lomb) with that of limbal relaxing incisional surgery combined with a non toric IOL (model MX60 - Bausch \\& Lomb) in patients with corneal astigmatism between 1.0 and 1.5 diopters and also the effect of cylinder reduction on patient's quality of vision.", 'detailedDescription': 'This is a randomised controlled trial with intra-patient comparison (bilateral study) in which study patients will be randomized by a medical statistician to the implantation of the toric intraocular lens (IOL) (model MX60T, Bausch \\& Lomb) in one eye and the non-toric IOL model MX60 plus LRI in the fellow eye.\n\nDuring pre-operative examination, the patient will undergo:\n\n* An ophthalmic examination including slit lamp biomicroscopy and retinal examination;\n* Uncorrected and best-corrected visual acuity (UCVA and BCVA): monocular and binocular;\n* Optical biometry with IOLMaster (Carl Zeiss Meditec);\n* Orbscan corneal topography (Bausch and Lomb Orbscan IIz Corneal Analysis System);\n* Quality of Vision (QoV) questionnaire score). It is a validated, Rasch-adjusted questionnaire in which patients are asked to rate 10 dysphotopsia items illustrated by standard photographs, scoring each item (0, 1, 2, 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total).\n* Catquest 9-SF cataract visual disability questionnaire. It is a Rasch-adjusted cataract visual disability questionnaire that asks patients to rate difficulty with a range of vision-related daily activities.\n\nThe appropriate cylinder power of the MX60T toric-IOL as well of its axis of implantation will be calculated with the calculator provided by the manufacturer Bausch + Lomb (https://trulign.toriccalculator.com).\n\nSubsequently, the patient will undergo cataract surgery with IOL implantation under local anaesthesia.\n\nThe temporal self-sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag will be performed as standard procedure.\n\nAccording to randomisation, each patient will receive the implantation of the MX60T toric-IOL in one eye and the MX60 non-toric IOL combined with limbal relaxing incisions (LRI) in the fellow eye.\n\nThe eye that will receive the toric-IOL will have the horizontal meridian marked preoperatively at the limbus in the sitting position with a blue marking pen and insulin syringe.\n\nThe IOL will be implanted via injector into the capsular bag using the manufacturers\' recommended IOL loading and injection technique.\n\nThe toric-IOL will be rotated in the capsular bag so that the axis markers on the IOL will be aligned to the limbal markings (planned axis). Then, the viscoelastic substance will be aspirated thoroughly from the eye. Final refinement of axis position of the IOL will be undertaken after removal of viscoelastic material from the capsular bag to ensure that irrigation/aspiration of viscoelastic does not move the lens off axis.\n\nThe fellow eye will receive a temporal or an on-axis incision with limbal relaxing incision with a 600µm single-use steel blade combined with the MX60 non-toric IOL (http://www.lricalculator.com).\n\nThe interval between the first and second eye surgery will be recorded. The location and length of the LRIs will be made after calculation according to the Donnenfeld nomogram (www.lricalculator.com).\n\nAfter one hour postoperatively, a photo of the toric-IOL in retroillumination will be taken to evaluate if IOL is on axis.\n\nAt six months and twelve months after the surgery performed in the second eye, patients will undergo assessement of:\n\n* autorefraction;\n* unaided and best-spectacle corrected visual acuity (monocular and binocular),\n* optical biometry;\n* corneal topography;\n* photo of the toric-IOL in retroillumination (to evaluate if IOL is on axis);\n* Catquest 9-SF cataract visual disability questionnaire;\n* Quality of Vision (QoV) questionnaire score;\n* Overall satisfaction with vision rating questionnaire (only at 6 months and 12 months). It will be obtained by asking patients to rate whether they were very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, or very unsatisfied.\n* Dysphotopsia questionnaire. They are 4 questions regarding dysphotopsia symptoms: "Since your surgery, have you noticed any" halo, glare or dazzle, unwanted images, or shadows? Patients were asked to respond by indicating whether they had not experienced these symptoms at all ("none") or found them "barely noticeable," "annoying," or "debilitating."\n\nStatistical analysis will be performed using SPSS for Macintosh software (version 20.0, International Business Machines Corp.). Normality distribution will be tested with the Shapiro-Wilk test; data will be considered normal if the p value is less than 0.05. The central tendency and statistical dispersion of each parameter will be recorded as the mean and standard deviation (SD) for normal data and as the median and interquartile difference for nonparametric data. The coordinates of keratometric cylinders and the centroids will be calculated according to the Alpins method. Double-angle polar plots will be used to display the astigmatism analysis (Excel 2011 for Macintosh, Microsoft Corp.).\n\nThe Student t test for paired samples and the Wilcoxon signed-rank test will be used for normal and nonparametric data, respectively, to compare the 2 related samples.\n\nA statistically significant difference will be defined as a p value less than 0.05.\n\nAny adverse event will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral cataract.\n* Age 21 and older.\n* Written informed consent to sequential bilateral surgery and participation in the study.\n* Preoperative pupil size greater than or equal to 5.0 mm in the study eye.\n* IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes.\n* Regular corneal astigmatism according to Orbscan topography.\n* Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com).\n\nExclusion Criteria:\n\n* Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA\n* Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)\n* Irregular corneal astigmatism on Orbscan topography'}, 'identificationModule': {'nctId': 'NCT03633851', 'briefTitle': 'Toric IOL vs Non-toric IOL With LRI for Corneal Astigmatism', 'organization': {'class': 'OTHER', 'fullName': "Ashford and St. Peter's Hospitals NHS Trust"}, 'officialTitle': 'Toric Intraocular Lens (IOL) Implantation Compared to Incisional Surgery to Correct Corneal Astigmatism as Part of Cataract Surgery - A Randomised Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'ASPH2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toric intraocular MX60T lens', 'description': 'one eye will receive toric MX60T lens', 'interventionNames': ['Device: Toric intraocular MX60T lens']}, {'type': 'OTHER', 'label': 'Standard MX60 plus corneal incisions', 'description': 'the other eye will receive standard MX60 lens with corneal incisions', 'interventionNames': ['Other: Standard MX60 plus corneal incisions']}], 'interventions': [{'name': 'Toric intraocular MX60T lens', 'type': 'DEVICE', 'description': 'one eye will receive toric MX60T lens', 'armGroupLabels': ['Toric intraocular MX60T lens']}, {'name': 'Standard MX60 plus corneal incisions', 'type': 'OTHER', 'description': 'the other eye will receive standard MX60 lens with corneal incisions', 'armGroupLabels': ['Standard MX60 plus corneal incisions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT16 0PZ', 'city': 'Chertsey', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Freda Gomes', 'role': 'CONTACT', 'email': 'freda.gomes@nhs.net', 'phone': '01932723534'}, {'name': 'Vinod Gangwani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr Isaac John', 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}], 'centralContacts': [{'name': 'Isaac John, PhD', 'role': 'CONTACT', 'email': 'Isaac.John@nhs.net', 'phone': '0044 193 272 2901'}, {'name': 'Freda Gomes, MSc', 'role': 'CONTACT', 'email': 'Freda.Gomes@nhs.net', 'phone': '0044 193 272 6664'}], 'overallOfficials': [{'name': 'Vinod Gangwani, MBBS FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ashford and St. Peter's Hospitals NHS Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ashford and St. Peter's Hospitals NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}