Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-26 @ 12:35 AM
Study NCT ID:
NCT02423668
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2015-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2015-04-19', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Second eye mean absolute error', 'timeFrame': '4-6 weeks after second eye surgery', 'description': 'Mean of the absolute value of the prediction error of the second eye'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract surgery', 'biometry', 'second eye refinement', 'effective lens position'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To study the effective lens position concept in second eye refinement (SER) cataract surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in Pentacam and SER refractive outcomes.', 'detailedDescription': 'A retrospective chart review was conducted, including demographics (age and gender) and several parameters for both the first and second eyes, including the intra-ocular lens power calculation using the HofferQ, SRK/T and Holladay 1 formulas. Pentacam HR was used for pseudophakic anterior chamber depth measurement, and manual measurement was performed by a single investigator tracing a line between the anterior surface of the intra-ocular lens and the central corneal epithelium apex. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the prediction error of the first eye. To relate refractive outcomes to pACD values, the investigators performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited from the electronic database of a single ophthalmological center as having performed bilateral cataract surgery between 1st June 2013 and 24th July 2014', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted for bilateral age-related cataract surgery\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Previous or combined ocular surgery\n* Manual extracapsular cataract extraction and not phacoemulsification\n* Corneal sutures\n* Implantation of any other IOL type\n* IOL implanted in the sulcus\n* Intra or postoperative complication\n* Post-operative best-corrected visual acuity worse than 5/10\n* Anterior corneal astigmatism\\>3.00 D\n* Inadequate cooperation for Pentacam HR examination'}, 'identificationModule': {'nctId': 'NCT02423668', 'briefTitle': 'Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Baixo Vouga'}, 'officialTitle': 'Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery', 'orgStudyIdInfo': {'id': 'CHBaixoVouga3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '50% Partial adjustment', 'description': 'The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the PE1. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).', 'interventionNames': ['Procedure: 50% Partial adjustment']}, {'label': 'No adjustment', 'description': 'The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. The intra-ocular lens power selection for the second eye was performed irrespective of the first eye prediction error. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).', 'interventionNames': ['Procedure: No adjustment']}, {'label': 'Full adjustment', 'description': 'The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 100% partial adjustment of the PE1. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).', 'interventionNames': ['Procedure: Full adjustment']}], 'interventions': [{'name': '50% Partial adjustment', 'type': 'PROCEDURE', 'description': 'Second eye refinement in the IOL power selection for the second eye using a theoretical 50% partial adjustment of the PE1.', 'armGroupLabels': ['50% Partial adjustment']}, {'name': 'No adjustment', 'type': 'PROCEDURE', 'description': 'IOL power selection for the second eye irrespective of first eye prediction error', 'armGroupLabels': ['No adjustment']}, {'name': 'Full adjustment', 'type': 'PROCEDURE', 'description': 'Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.', 'armGroupLabels': ['Full adjustment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pedro Gil, MSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar Baixo Vouga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar do Baixo Vouga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, MD', 'investigatorFullName': 'Pedro Gil', 'investigatorAffiliation': 'Centro Hospitalar do Baixo Vouga'}}}}