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Axial Length Variability

Evaluation of Axial Length Changes Between Pre and Postoperative Measurements

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04580550
Enrollment
50
Registered
2020-10-08
Start date
2019-11-01
Completion date
2020-03-01
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

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

Interventions

OTHERAxial length variability

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.

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Axial length variability3 monthsEvaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers

Secondary

MeasureTime frameDescription
Lens tilt and decentration3 monthsEvaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026