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

NCT ID: NCT01784926

Last Updated: 2019-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Intraocular Lens Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Investigator masked for group affiliation during image analysis

Study Groups

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IOL repositioning

Operation method: Intraocular lens repositioning by scleral suturing

Group Type OTHER

Intraocular lens repositioning by scleral suturing

Intervention Type PROCEDURE

IOL exchange

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

Group Type OTHER

Intraocular lens exchange with retropupillary iris-claw lens

Intervention Type PROCEDURE

Interventions

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Intraocular lens repositioning by scleral suturing

Intervention Type PROCEDURE

Intraocular lens exchange with retropupillary iris-claw lens

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marius Dalby

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liv Drolsum, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 33754659 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28973318 (View on PubMed)

Other Identifiers

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2012/1981

Identifier Type: -

Identifier Source: org_study_id

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