- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02423668
Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
April 21, 2015 updated by: Pedro Gil, Centro Hospitalar do Baixo Vouga
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
88
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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
Description
Inclusion Criteria:
- patients admitted for bilateral age-related cataract surgery
Exclusion Criteria:
- Age < 18 years old
- Previous or combined ocular surgery
- Manual extracapsular cataract extraction and not phacoemulsification
- Corneal sutures
- Implantation of any other IOL type
- IOL implanted in the sulcus
- Intra or postoperative complication
- Post-operative best-corrected visual acuity worse than 5/10
- Anterior corneal astigmatism>3.00 D
- Inadequate cooperation for Pentacam HR examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
50% Partial adjustment
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).
|
Second eye refinement in the IOL power selection for the second eye using a theoretical 50% partial adjustment of the PE1.
|
No adjustment
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).
|
IOL power selection for the second eye irrespective of first eye prediction error
|
Full adjustment
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).
|
Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Second eye mean absolute error
Time Frame: 4-6 weeks after second eye surgery
|
Mean of the absolute value of the prediction error of the second eye
|
4-6 weeks after second eye surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro Gil, MSc, MD, Centro Hospitalar Baixo Vouga
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
April 19, 2015
First Submitted That Met QC Criteria
April 21, 2015
First Posted (Estimate)
April 22, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHBaixoVouga3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cataract
-
Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
-
Johannes Kepler University of LinzCompletedCataract Complicated | Cataract Complications OperationsAustria
-
Gemini Eye ClinicRecruitingBilateral Cataract | Unilateral CataractCzechia
-
Universitaire Ziekenhuizen KU LeuvenLaboratoires TheaRecruiting
-
Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
-
Yonsei UniversityCompletedCataract PatientsKorea, Republic of
-
Johannes Kepler University of LinzRecruitingAphakia | Secondary Cataract Surgery | Complicated Cataract SurgeryAustria
-
Advanced Center for Eyecare GlobalNot yet recruiting
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingCataract ExtractionChina
Clinical Trials on 50% Partial adjustment
-
Life UniversityRecruiting
-
Life UniversityCompletedBrain FunctionUnited States
-
Istanbul UniversityRecruitingPostoperative Complications | Postoperative Delirium | Emergence Delirium | Anesthesia | Anesthesia Awareness | Behavior Child ProblemsTurkey
-
Life UniversityUniversity of GeorgiaCompletedCognition - OtherUnited States
-
Samsung Medical CenterCompletedBrain Surgery With Motor Evoked Potential Monitoring | Spine Surgery With Motor Evoked Potential MonitoringKorea, Republic of
-
Chen LingPrince of Wales Hospital, Shatin, Hong Kong; Shenzhen Second People's HospitalCompleted
-
Logan College of ChiropracticUnknown
-
Milton S. Hershey Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Universitat Jaume IMinisterio de Economía y Competitividad, SpainUnknownOnline Computerized Program Group | Waiting List Control GroupSpain
-
Life UniversityRecruitingMetabolic SyndromeUnited States