NCT05915429

Brief Summary

Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt is one type of misalignment that is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric or multifocal optics. Due to the fact that tilt has an influence on visual quality, the prediction of the post-operative tilt could improve IOL power calculaton significantly especially for toric IOLs. the Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 5, 2022

Last Update Submit

October 3, 2023

Conditions

Cataract

Keywords

IOLtiltOCTScheimpflug

Outcome Measures

Primary Outcomes (1)

  • change of amount of tilt

    difference between preoperative amount of tilt in degrees and postoperative tilt in degrees

    preoperation visit and 8 weeks postoperation visit

Other Outcomes (9)

  • change of orientation of tilt in degrees

    pre operation visit and 8 weeks post operation visit

  • axial eye length

    pre operation visit and 8 weeks post operation visit

  • anterior chamber depth

    pre operation visit and 8 weeks post operation visit

  • +6 more other outcomes

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with planned cataract surgery

You may qualify if:

  • planned cataract surgery in one or both eyes
  • above 21 years of age

You may not qualify if:

  • Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
  • Best corrected distance visual acuity below 0.05 Snellen
  • Pathologies that could have an influence on the post-operative tilt, such as pseudoexfoliation syndrome or previous ophthalmic trauma, or other reasons for phakodonesis.
  • Previous ophthalmic surgery that could have an influence on post-operative tilt such as pars plana vitrectomy
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4021, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Matthias Bolz, MD

    JKU Linz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

June 23, 2023

Study Start

April 12, 2022

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

AU(1)