NCT03749798

Brief Summary

Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

November 20, 2018

Last Update Submit

November 20, 2018

Conditions

Cataract

Keywords

CataractWavefront measurement

Outcome Measures

Primary Outcomes (1)

  • Wavefront aberration measurements

    Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).

    12 months

Study Arms (1)

Intraoperative wavefront measurement

EXPERIMENTAL

Patients will be measured with an intraoperative wavefront device during cataract surgery

Procedure: Cataract surgery

Interventions

Cataract surgeryPROCEDURE

Intraoperative wavefront measurements will be carried out during cataract surgery

Intraoperative wavefront measurement

Eligibility Criteria

Age21 Years - 105 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • Age 21 and older
  • Able to understand the patient information
  • Willing to follow the instructions and attend all follow-up visits
  • Willing to sign informed consent prior to surgery

You may not qualify if:

  • Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
  • Previous ocular surgeries on the study eye
  • Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
  • Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Julius Hienert, MD

CONTACT

01 910 21-57564office@viros.at

Nino Hirnschall, MD

CONTACT

01 910 21-57564office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

September 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

AU(1)