Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01784926
First received: January 29, 2013
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

In this prospective, randomized study The investigators will include 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.


Condition Intervention
IOL-dislocation
Procedure: Scleral suturing versus IOL exhange

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intraocular pressure (IOP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Endothelial density [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Keratometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Questionaire Visual function (VF-14) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    About visual function

  • IOL location [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure IOL's location with slit lamp and Pentacam.


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Surgical treatment Procedure: Scleral suturing versus IOL exhange

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with total dislocation of the capsular complex'
  • patients with reduced general health
  • patients who can't be randomized
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784926

Contacts
Contact: Marianne Raaen uxrenm@ous-hf.no

Locations
Norway
Recruiting
Oslo, Norway
Contact: Marianne Raaen       uxrenm@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01784926     History of Changes
Other Study ID Numbers: 2012/1981
Study First Received: January 29, 2013
Last Updated: February 18, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
cataract surgery
scleral suturing
Verisyse

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014