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

Primary Purpose

Intraocular Lens Dislocation

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Intraocular lens repositioning by scleral suturing

Intraocular lens exchange with retropupillary iris-claw lens

About this trial

This is an interventional treatment trial for Intraocular Lens Dislocation focused on measuring cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

IOL repositioning

IOL exchange

Arm Description

Operation method: Intraocular lens repositioning by scleral suturing

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

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (BCVA)

Measure for visual function. Measured in logMAR

Intraocular Pressure (IOP)

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

Endothelial Density

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

Postoperative Complications

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

Secondary Outcome Measures

Keratometry

Keratometry of the cornea. Corneal astigmatism, measured in diopters.

Questionnaire Visual Function-14 (VF-14) Score

Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).

IOL Location

Measure IOL's location with slit lamp and Pentacam.

Full Information

NCT ID

NCT01784926

First Posted

January 29, 2013

Last Updated

September 2, 2019

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01784926

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

In this prospective, randomized study The investigators will include at least 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraocular Lens Dislocation

Keywords

cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Investigator masked for group affiliation during image analysis

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IOL repositioning

Arm Type

Other

Arm Description

Operation method: Intraocular lens repositioning by scleral suturing

Arm Title

IOL exchange

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Intraocular lens repositioning by scleral suturing

Intervention Type

Procedure

Intervention Name(s)

Intraocular lens exchange with retropupillary iris-claw lens

Primary Outcome Measure Information:

Title

Best Corrected Visual Acuity (BCVA)

Description

Measure for visual function. Measured in logMAR

Time Frame

6 months, 1 year and 2 years

Title

Intraocular Pressure (IOP)

Description

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

Time Frame

6 months and 2 years

Title

Endothelial Density

Description

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

Time Frame

6 months

Title

Postoperative Complications

Description

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

Time Frame

6 months and 2 years

Secondary Outcome Measure Information:

Title

Keratometry

Description

Keratometry of the cornea. Corneal astigmatism, measured in diopters.

Time Frame

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

Title

Questionnaire Visual Function-14 (VF-14) Score

Description

Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).

Time Frame

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

Title

IOL Location

Description

Measure IOL's location with slit lamp and Pentacam.

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liv Drolsum, MD, PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

33754659

Citation

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.

Results Reference

derived

PubMed Identifier

28973318

Citation

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.

Results Reference

derived

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

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