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OpenTrials
Completed

NCT Number: NCT04580550

Axial Length Variability

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.

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Key information

Conditions

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanusch Hospital, Ophthalmology department

Vienna, 1140, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axial length variability

Other

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 outcomes

  1. Axial length variability

    Time frame: 3 months

    Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers

Secondary outcomes

  1. Lens tilt and decentration

    Time frame: 3 months

    Evaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Evaluation of Axial Length Changes Between Pre and Postoperative Measurements

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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