Dislocated Intraocular LensNCT04150263
Modification of Scleral Suture Fixation of Dislocated IOL
A study testing Intraocular lens (IOL) ab externo scleral suture fixation and Modified IOL ab externo scleral suture fixation in people with Dislocated Intraocular Lens, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dislocated Intraocular Lens
- What is being tested?
- Intraocular lens (IOL) ab externo scleral suture fixation and Modified IOL ab externo scleral suture fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSweden
- Study dates
- 12 Nov 2018to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 in-the-bag dislocated IOL who agree to participate in the study
- Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery.
Who cannot join
- patients with dislocated IOL that is not visible in the pupillary plane
- IOL design not suitable for suturing using capsular bag
- patients who are not able to cooperate under measurements
- patients with Marfan syndrome and ectopia lentis
- exclusion criterion for the control group: other eye surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dislocated Intraocular Lenses: Effect of Modification of Surgical Repositioning and Capsular Fibrosis Impact on Position of IOL After Fixation Surgery in a Randomized Trial
A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.
Read the detailed description
In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.
- Conditions
- Dislocated Intraocular Lens
- Being tested
- Intraocular lens (IOL) ab externo scleral suture fixation, Modified IOL ab externo scleral suture fixation
- Keywords
- intraocular lens, dislocation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lens (IOL) ab externo scleral suture fixationProcedure or surgery
traditional IOL scleral suture fixation
Modified IOL ab externo scleral suture fixationProcedure or surgery
Modified IOL scleral suture fixation
| Study group | Role | What they receive |
|---|---|---|
| Traditional IOL repositioning | Other | Intraocular lens (IOL) ab externo scleral suture fixation Receives: Procedure: Intraocular lens (IOL) ab externo scleral suture fixation |
| Modification of traditional IOL repositioning | Other | Modified intraocular lens (IOL) ab externo scleral suture fixation Receives: Procedure: Modified IOL ab externo scleral suture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL position
Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
Measured: through study completion, an average of 1,5 years
Capsular thickness
Measured with OCT and photographed on slit-lamp examination.
Measured: preoperatively or as soon as possible postoperatively
Astigmatism
Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively,
Measured: through study completion, an average of 1,5 years
Secondary outcomes (6)
Best Corrected Visual Acuity (BCVA)
Measure for visual function. Measured in logMAR. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
Measured: through study completion, an average of 1,5 years
Intraocular Pressure (IOP)
Measure for the pressure inside the eye measured with Goldman applanation tonometer and iCare, both in mmHg. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
Measured: through study completion, an average of 1,5 years
administration of IOL lowering therapy
number of patients who used IOL lowering therapy
Measured: through study completion, an average of 1,5 years
Number of participants with postoperative complications
Number of patients with retinal detachment, macular edema and other.
Measured: through study completion, an average of 1,5 year
Precision of the IOL position measurement with OCT
Measurements of IOL position with OCT will be done 3 times by the same investigator in both mydriatic and non-mydriatic pupil status.
Measured: 1 month or any other postoperative control through study completion, an average of 1,5 year
inflammation in anterior chamber
Measured at 2 time points: 6 months and 1.5 years postoperatively, with laser flare meter.
Measured: through study completion, an average of 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start12 Nov 2018
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislocated Intraocular LensStudies of the same condition, open and under way.
- 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
- Model description
- 1 arm included 56 patients, the other arm included 61 patients. Sixty controls with ordinary pseudophakia.
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Erik Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Principal investigator, Laura Armonaite, St. Erik Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150263
- Sponsor's protocol ID
- 2018/1838 - 31/2
- Status last verified
- Apr 2024
- First submitted
- 29 Oct 2019
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dislocated Intraocular Lenses: Effect of Modification of Surgical Repositioning and Capsular Fibrosis Impact on Position of IOL After Fixation Surgery in a Randomized Trial
- ClinicalTrials.gov ID
- NCT04150263
- Acronym / sponsor ID
- 2018/1838 - 31/2
- Conditions
- Dislocated Intraocular Lens
- Keywords
- intraocular lens, dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.
Detailed description
In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 arm included 56 patients, the other arm included 61 patients. Sixty controls with ordinary pseudophakia.
| Arm | Type | Receives |
|---|---|---|
| Traditional IOL repositioning | Other | Procedure: Intraocular lens (IOL) ab externo scleral suture fixationIntraocular lens (IOL) ab externo scleral suture fixation |
| Modification of traditional IOL repositioning | Other | Procedure: Modified IOL ab externo scleral suture fixationModified intraocular lens (IOL) ab externo scleral suture fixation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with in-the-bag dislocated IOL who agree to participate in the study
- Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery.
Key exclusion criteria (5 listed)
- patients with dislocated IOL that is not visible in the pupillary plane
- IOL design not suitable for suturing using capsular bag
- patients who are not able to cooperate under measurements
- patients with Marfan syndrome and ectopia lentis
- exclusion criterion for the control group: other eye surgery.
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 (IOL) ab externo scleral suture fixationtraditional IOL scleral suture fixation | Procedure or surgery | Traditional IOL repositioning |
| Modified IOL ab externo scleral suture fixationModified IOL scleral suture fixation | Procedure or surgery | Modification of traditional IOL repositioning |
Primary outcome
IOL position
Time frame: through study completion, an average of 1,5 years
Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
Capsular thickness
Time frame: preoperatively or as soon as possible postoperatively
Measured with OCT and photographed on slit-lamp examination.
Astigmatism
Time frame: through study completion, an average of 1,5 years
Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively,
6 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: through study completion, an average of 1,5 years
Intraocular Pressure (IOP)
Time frame: through study completion, an average of 1,5 years
administration of IOL lowering therapy
Time frame: through study completion, an average of 1,5 years
Number of participants with postoperative complications
Time frame: through study completion, an average of 1,5 year
Precision of the IOL position measurement with OCT
Time frame: 1 month or any other postoperative control through study completion, an average of 1,5 year
inflammation in anterior chamber
Time frame: through study completion, an average of 1,5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens (IOL) ab externo scleral suture fixation and Modified IOL ab externo scleral suture fixation in people with Dislocated Intraocular Lens, run by St. Erik Eye Hospital at 1 site in Sweden.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 24 Apr 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOL position (time frame: through study completion, an average of 1,5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2024.