NCT01784926

Brief Summary

A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.

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
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

January 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 27, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

January 29, 2013

Results QC Date

April 19, 2017

Last Update Submit

September 2, 2019

Conditions

Intraocular Lens Dislocation

Keywords

cataract surgeryscleral suturingVerisyseLate in-the-bag IOL dislocation

Outcome Measures

Primary Outcomes (4)

  • Best Corrected Visual Acuity (BCVA)

    Measure for visual function. Measured in logMAR

    6 months, 1 year and 2 years

  • Intraocular Pressure (IOP)

    Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.

    6 months and 2 years

  • Endothelial Density

    Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter

    6 months

  • Postoperative Complications

    Cystoid macular edema considered the most important long-term complication and therefore reported here.

    6 months and 2 years

Secondary Outcomes (3)

  • Keratometry

    6 months (only analyzed/reported for this time frame)

  • Questionnaire Visual Function-14 (VF-14) Score

    6 months (only analyzed/reported for this time frame)

  • IOL Location

    2 years

Study Arms (2)

IOL repositioning

OTHER

Operation method: Intraocular lens repositioning by scleral suturing

Procedure: Intraocular lens repositioning by scleral suturing

IOL exchange

OTHER

Operation method: Intraocular lens exchange with retropupillary iris-claw lens

Procedure: Intraocular lens exchange with retropupillary iris-claw lens

Interventions

Intraocular lens repositioning by scleral suturingPROCEDURE
IOL repositioning
Intraocular lens exchange with retropupillary iris-claw lensPROCEDURE
IOL exchange

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with dislocation of IOL in the capsular complex who agree to participate in the study

You may not qualify if:

  • patients with total dislocation of the capsular complex'
  • patients with reduced general health
  • patients who can't be randomized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (2)

  • Dalby M, Drolsum L, Kristianslund O. Repositioning surgery of different intraocular lens designs in eyes with late in-the-bag intraocular lens dislocation. J Cataract Refract Surg. 2021 Sep 1;47(9):1147-1152. doi: 10.1097/j.jcrs.0000000000000588.

    PMID: 33754659DERIVED

  • Kristianslund O, Ostern AE, Drolsum L. Astigmatism and Refractive Outcome After Late In-The-Bag Intraocular Lens Dislocation Surgery: A Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4747-4753. doi: 10.1167/iovs.17-22723.

    PMID: 28973318DERIVED

Limitations and Caveats

Limitations to the study / the result: Some loss to follow-up Some missing data for some of the parameters

Results Point of Contact

Title
Dr. Olav Kristianslund
Organization
Oslo University Hospital
olav.kristianslund@medisin.uio.no
+4723015168

Study Officials

  • Liv Drolsum, MD, PhD

    Oslo University Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Investigator masked for group affiliation during image analysis
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 6, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 1, 2020

Last Updated

September 27, 2019

Results First Posted

September 27, 2019

Record last verified: 2019-09

Locations

NO(1)