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

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ClinicalTrials.gov Identifier: NCT01784926
Recruitment Status : Active, not recruiting
First Posted : February 6, 2013
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Marianne Råen, Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment
Intraocular Lens Dislocation Procedure: Intraocular lens repositioning by scleral suturing Procedure: Intraocular lens exchange with retropupillary iris-claw lens

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 6 months ]
  2. Intraocular pressure (IOP) [ Time Frame: 6 months ]
  3. Endothelial density [ Time Frame: 6 months ]
  4. Postoperative complications [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Keratometry [ Time Frame: 6 months ]
  2. Questionaire Visual function (VF-14) [ Time Frame: 6 months ]
    About visual function

  3. IOL location [ Time Frame: 6 months ]
    Measure IOL's location with slit lamp and Pentacam.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784926


Locations
Norway
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Marianne Råen, MSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01784926     History of Changes
Other Study ID Numbers: 2012/1981
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016

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

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