NCT01867541

Brief Summary

Refractive outcome after cataract surgery mainly depends on the prediction of the intraocular lens that is implanted in the eye during surgery. Aim of this study is to measure the position of the lens capsule during surgery and to use this measurements to improve post-operative refractive outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

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

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

June 4, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

May 26, 2013

Last Update Submit

May 29, 2013

Conditions

Cataracts

Keywords

cataract surgeryintraocular lens power calculationeffective lens positionimproving the refractive outcome after cataract surgerypredicting the IOL position

Outcome Measures

Primary Outcomes (1)

  • Correlation of intra-operative lens capsule measurements and the post-operative lens position

    Aim of this outcome parameter is to detect, if intra-operative measurements (with an optical coherence tomogrophy system) help to detect the position of the artificial lens post-operatively

    3 months

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who are sceduled for cataract surgery

You may qualify if:

  • Cataract
  • Age 21 and older
  • written informed consent prior to surgery

You may not qualify if:

  • Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hirnschall N, Amir-Asgari S, Maedel S, Findl O. Predicting the postoperative intraocular lens position using continuous intraoperative optical coherence tomography measurements. Invest Ophthalmol Vis Sci. 2013 Aug 5;54(8):5196-203. doi: 10.1167/iovs.13-11991.

    PMID: 23761092DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Oliver Findl, MD, MBA

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prim. Prof. Dr., MBA

Study Record Dates

First Submitted

May 26, 2013

First Posted

June 4, 2013

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-05