NCT04580550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 30, 2020

Last Update Submit

October 7, 2020

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

  • Axial length variability

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

    3 months

Secondary Outcomes (1)

  • Lens tilt and decentration

    3 months

Study Arms (1)

Axial length variability

OTHER

Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.

Other: Axial length variability

Interventions

Axial length variabilityOTHER

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.

Axial length variability

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uneventful cataract surgery
  • Age 21 and older
  • Axial length 24.00 mm and bigger
  • CT Asphina 409 M lens implanted

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanusch Hospital, Ophthalmology department

Vienna, 1140, Austria

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Ophthalmology, Professor, Principal Investigator, MBA

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 8, 2020

Study Start

November 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

AU(1)