Axial Length Variability
Primary Purpose
Cataract Senile
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Axial length variability
Sponsored by
About this trial
This is an interventional other trial for Cataract Senile
Eligibility Criteria
Inclusion Criteria:
- Uneventful cataract surgery
- Age 21 and older
- Axial length 24.00 mm and bigger
- CT Asphina 409 M lens implanted
Exclusion Criteria:
- Intra- or postoperative complication
- Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
- Pregnancy
Sites / Locations
- Hanusch Hospital, Ophthalmology department
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Axial length variability
Arm Description
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
Outcomes
Primary Outcome Measures
Axial length variability
Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers
Secondary Outcome Measures
Lens tilt and decentration
Evaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices
Full Information
NCT ID
NCT04580550
First Posted
September 30, 2020
Last Updated
October 7, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT04580550
Brief Title
Axial Length Variability
Official Title
Evaluation of Axial Length Changes Between Pre and Postoperative Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.
AL difference in pre and postoperative measurements may be caused by changes of lens parameters.
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
Detailed Description
This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.
In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.
Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.
Additionally, evaluation of tilt and decentration will be performed using Purkinje meter device.
Follow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.
In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Main outcome variable:
• Extend of AL difference between pre- and postoperative measurements in both devices
Additional outcome variables:
Agreement between the two ss-OCT devices in AL measurement
Evaluation of lens parameter in AL differences between pre- and postoperative measurements
Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje meter
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Axial length variability
Arm Type
Other
Arm Description
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
Intervention Type
Other
Intervention Name(s)
Axial length variability
Intervention Description
Biometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively.
Primary Outcome Measure Information:
Title
Axial length variability
Description
Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lens tilt and decentration
Description
Evaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uneventful cataract surgery
Age 21 and older
Axial length 24.00 mm and bigger
CT Asphina 409 M lens implanted
Exclusion Criteria:
Intra- or postoperative complication
Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
Pregnancy
Facility Information:
Facility Name
Hanusch Hospital, Ophthalmology department
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
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Axial Length Variability
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