Intraocular Lens DislocationNCT01784926

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

A study testing Intraocular lens repositioning by scleral suturing and Intraocular lens exchange with retropupillary iris-claw lens in people with Intraocular Lens Dislocation, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Intraocular Lens Dislocation
What is being tested?: Intraocular lens repositioning by scleral suturing and Intraocular lens exchange with retropupillary iris-claw lens
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteNorway
Study dates: Jan 2013to Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

patients with total dislocation of the capsular complex'
patients with reduced general health
patients who can't be randomized

Trial locations and contacts

1 site in 1 country.

Norway1 site

Oslo University Hospital
Oslo

Other trials in Norway

About this study

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.

Read the 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.

Conditions: Intraocular Lens Dislocation
Being tested: Intraocular lens repositioning by scleral suturing, Intraocular lens exchange with retropupillary iris-claw lens
Keywords: cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intraocular lens repositioning by scleral suturingProcedure or surgery
Intraocular lens exchange with retropupillary iris-claw lensProcedure or surgery

Study groups in NCT01784926
Study group	Role	What they receive
IOL repositioning	Other	Operation method: Intraocular lens repositioning by scleral suturing Receives: Procedure: Intraocular lens repositioning by scleral suturing
IOL exchange	Other	Operation method: Intraocular lens exchange with retropupillary iris-claw lens Receives: Procedure: Intraocular lens exchange with retropupillary iris-claw lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Best Corrected Visual Acuity (BCVA)
Measure for visual function. Measured in logMAR
Measured: 6 months, 1 year and 2 years
Intraocular Pressure (IOP)
Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
Measured: 6 months and 2 years
Endothelial Density
Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter
Measured: 6 months
Postoperative Complications
Cystoid macular edema considered the most important long-term complication and therefore reported here.
Measured: 6 months and 2 years

Secondary outcomes (3)

Keratometry
Keratometry of the cornea. Corneal astigmatism, measured in diopters.
Measured: 6 months (only analyzed/reported for this time frame)
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).
Measured: 6 months (only analyzed/reported for this time frame)
IOL Location
Measure IOL's location with slit lamp and Pentacam.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2020

First posted6 Feb 2013 (estimated)
Study startJan 2013
Primary completionJun 2016
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Intraocular Lens DislocationStudies of the same condition, open and under way.
More trials run by Oslo University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01784926
Sponsor's protocol ID: 2012/1981
Status last verified: Sep 2019
First submitted: 29 Jan 2013
Last updated: 27 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33754659
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.
PubMed 28973318

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods
ClinicalTrials.gov ID: NCT01784926
Acronym / sponsor ID: 2012/1981
Conditions: Intraocular Lens Dislocation
Keywords: cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 104 participants (actual)
Lead sponsor: Oslo University HospitalUniversity, hospital or other
Study start: Jan 2013
Primary completion: Jun 2016 (actual)
Study completion: Dec 2020 (estimated)
First posted: 6 Feb 2013 (estimated)
Results: Posted 27 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IOL repositioning	Other	Procedure: Intraocular lens repositioning by scleral suturingOperation method: Intraocular lens repositioning by scleral suturing
IOL exchange	Other	Procedure: Intraocular lens exchange with retropupillary iris-claw lensOperation method: Intraocular lens exchange with retropupillary iris-claw lens

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

patients with total dislocation of the capsular complex'
patients with reduced general health
patients who can't be randomized

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intraocular lens repositioning by scleral suturing	Procedure or surgery	IOL repositioning
Intraocular lens exchange with retropupillary iris-claw lens	Procedure or surgery	IOL exchange

Primary outcome

Best Corrected Visual Acuity (BCVA)
Time frame: 6 months, 1 year and 2 years
Measure for visual function. Measured in logMAR
Intraocular Pressure (IOP)
Time frame: 6 months and 2 years
Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
Endothelial Density
Time frame: 6 months
Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter
Postoperative Complications
Time frame: 6 months and 2 years
Cystoid macular edema considered the most important long-term complication and therefore reported here.

3 secondary outcomes

Keratometry
Time frame: 6 months (only analyzed/reported for this time frame)
Questionnaire Visual Function-14 (VF-14) Score
Time frame: 6 months (only analyzed/reported for this time frame)
IOL Location
Time frame: 2 years

Results and safety

Results posted to the registry on 27 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IOL Repositioning	54	43
IOL Exchange	50	42

Primary outcome: Best Corrected Visual Acuity (BCVA)

Time frame: 6 months, 1 year and 2 years. Mean (Standard Deviation). Unit: logMAR

Measure	IOL Repositioning n = 43	IOL Exchange n = 42
BCVA 6 months	0.24 (0.29)	0.35 (0.54)
BCVA 1 year	0.21 (0.26)	0.23 (0.34)
BCVA 2 years	0.20 (0.29)	0.22 (0.30)

Primary outcome: Intraocular Pressure (IOP)

Time frame: 6 months and 2 years. Mean (Standard Deviation). Unit: mmHg

Measure	IOL Repositioning n = 43	IOL Exchange n = 42
IOP 6 months	16.5 (5.2)	14.9 (4.2)
IOP 2 years	15.7 (4.0)	14.1 (4.2)

Primary outcome: Endothelial Density

Time frame: 6 months. Mean (Standard Deviation). Unit: cells/mm^2

Measure	IOL Repositioning n = 37	IOL Exchange n = 33
Value	1858 (433)	1514 (470)

Population analysed: Some missing data due to inadequate corneal images

Primary outcome: Postoperative Complications

Time frame: 6 months and 2 years. Count of participants. Unit: Participants

Measure	IOL Repositioning n = 43	IOL Exchange n = 42
CME 6 months: Cystoid macular edema	3	4
CME 6 months: No cystoid macular edema	40	38
CME 2 years: Cystoid macular edema	5	6
CME 2 years: No cystoid macular edema	38	36

Population analysed: Some loss to follow-up

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IOL Repositioning	10 of 54 (18.5%)	3 of 43 (7%)	1 of 54
IOL Exchange	8 of 50 (16%)	4 of 42 (9.5%)	0 of 50

Limitations and caveats (from the sponsor): Limitations to the study / the result: Some loss to follow-up Some missing data for some of the parameters

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33754659Dalby 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.
Derived from this study: PubMed 28973318Kristianslund 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Liv Drolsum, MD, PhD study chair

Oslo University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Corrected Visual Acuity (BCVA) (time frame: 6 months, 1 year and 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01784926, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.