NCT03276104

Brief Summary

Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 9, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

August 31, 2017

Last Update Submit

April 16, 2019

Conditions

Intraocular Lens Dislocation

Keywords

IOL dislocationCataractCataract surgeryScleral suturingVerisyseIris-clawLate in-the-bag IOL dislocation

Outcome Measures

Primary Outcomes (3)

  • Inflammation in the anterior chamber after surgery

    Measured with a Laser Flare Meter

    The first weeks after surgery

  • Changes in macular thickness and occurrence of Cystoid macular edema

    Evaluated with Optical Coherence Tomography

    The first months after surgery, and long term changes months up to two years after surgery

  • Intraocular pressure changes

    Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg

    Early changes in the first weeks after surgery, and long term changes months up to two years after surgery

Secondary Outcomes (12)

  • Best Corrected Visual acuity (BCVA)

    Short term (the first weeks and up to 6 months) and long term (up to two years)

  • Best Corrected Visual acuity (BCVA)

    Short term (the first weeks and up to 6 months) and long term (up to two years)

  • Glare

    Medium term (6 months)

  • Glare

    Medium term (6 months)

  • Endothelial cells

    Short term (2 weeks) and long term (6months and 2 years)

  • +7 more secondary outcomes

Study Arms (2)

IOL repositioning group

ACTIVE COMPARATOR
Procedure: IOL repositioning

IOL exchange group

ACTIVE COMPARATOR
Procedure: IOL exchange

Interventions

IOL repositioningPROCEDURE

Intraocular lens repositioning by scleral suturing

IOL repositioning group
IOL exchangePROCEDURE

Intraocular lens exchange with retropupillary iris-claw lens

IOL exchange group

Eligibility Criteria

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

You may qualify if:

  • IOL inside the capsule ("in-the-bag")
  • Late dislocation (more than 6 months after cataract surgery)
  • IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
  • Eligibility for both operation methods
  • Ability to cooperate fairly well during the examinations
  • Willing to participate in the study, e.g. willingness to participate at all control visits

You may not qualify if:

  • IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
  • Eyes with especially thin sclera
  • Active uveitis or pronounced iris pathology
  • Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
  • Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
  • Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
  • Cases requiring a change in refraction. Risk of severe anisometropia
  • Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
  • Patients using anticoagulants that cannot be discontinued
  • For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Liv Drolsum, Prof. M.D. PhD

    Oslo University Hospital

    STUDY CHAIR

Central Study Contacts

Marius Dalby, M.D. PhD Cand.

CONTACT

+47 92408957marius.dalby@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D., PhD Candidate

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 8, 2017

Study Start

September 9, 2017

Primary Completion

November 1, 2020

Study Completion

December 1, 2022

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)