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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marianne Råen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01784926
First received: January 29, 2013
Last updated: June 21, 2016
Last verified: June 2016
  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
Intraocular Lens Dislocation
Procedure: Intraocular lens repositioning by scleral suturing
Procedure: Intraocular lens exchange with retropupillary iris-claw lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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: 6 months ] [ Designated as safety issue: No ]
  • Intraocular pressure (IOP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Endothelial density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Keratometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Questionaire Visual function (VF-14) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    About visual function

  • IOL location [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure IOL's location with slit lamp and Pentacam.


Enrollment: 104
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IOL repositioning
Operation method: Intraocular lens repositioning by scleral suturing
Procedure: Intraocular lens repositioning by scleral suturing
IOL exchange
Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Procedure: Intraocular lens exchange with retropupillary iris-claw lens

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
Norway
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
  More Information

Responsible Party: Marianne Råen, MSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01784926     History of Changes
Other Study ID Numbers: 2012/1981 
Study First Received: January 29, 2013
Last Updated: June 21, 2016
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
cataract surgery
scleral suturing
Verisyse
Late in-the-bag IOL dislocation

Additional relevant MeSH terms:
Dislocations
Lens Subluxation
Wounds and Injuries
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on December 07, 2016