ComplicationsNCT02747667
Characteristics and Risk Ratios of Late Intraocular Lens (IOL) Complication
An observational study of Complications, run by Medical University of Graz.
Trial summary
Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then several case reports and case series were observed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complications
- How many people
- 10,125 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with phacoemulsification and extracapsular cataract surgery with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.
Who may be able to join
- Phacoemulsification or extracapsular cataract extraction with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.
Who cannot join
- Intracapsular cataract extraction
About this study
Official title: Late Dislocation and Haptic Deformation of a Hydrophilic Intraocular Lens: Characteristics, Incidence Rates and Predisposing Factors
Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then several case reports and case series were observed. In-the-bag IOL dislocation is a well-known postoperative complication, especially in eyes with weak zonules as seen in pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).
In this retrospective study, medical records of all patients with IOL related problems after implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and predisposing factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic complications will be investigated and compared amongst each other or control patients. Incidence rates for each IOL complication will be calculated. For in-the-bag dislocations odds ratios for each predisposing factor will be calculated.
Read the detailed description
This is a retrospective cohort study. Data of all patients treated at the hospital from June 1997 to October 2015 for a complication after IOL implantation will be obtained from an electronic medical record and database (FileMaker Inc., v3 - 6 and EyMed). Additional data, e.g. axial length (AL) or diopters of the implanted IOL, are taken from the patients' medical files. Collected data are age, sex, laterality of the eye, and predisposing eye conditions (PXF, relevant myopia defined as ≥ 25.5 mm axial length, uveitis, RP and ocular trauma). Other parameters are preoperative surgical interventions, the use of a capsular tension ring (CTR), perioperative complications, diopters of the IOL, pre- and postoperative corrected distance visual acuity (CDVA) in logMAR, and post-operative manifest refraction. Time to dislocation, additional interventions after cataract surgery, and symptoms due to the IOL complication will recorded. Type of dislocation (in-the-bag or out-of-the-bag), location (anterior chamber, pupillary plane or vitreous), pre- and post-operative CDVA, pre- and post-operative manifest refraction, type of secondary intervention, and in case secondary implantation was performed, type of secondary IOL are collected.
Differences regarding prevalence for various predisposing risk factors are investigated by means of logistic regression methods. Odds ratios and 95% confidence intervals are calculated unadjusted as well as adjusted for age, gender, and the four predisposing risk factors: PXF, relevant myopia, uveitis, and RP. Prevalence and incidence of in-the-bag IOL dislocations will be calculated from all patients that had an implantation of the ACR6D SE at the Department of Ophthalmology in Graz.
- Conditions
- Complications
- Keywords
- iol dislocation, iol complication, intraocular lens, Implant or Graft, Eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eye with late IOL complication | Alle patients with IOL complication (subgroup: in-the-bag dislocation; out-of-the-bag dislocation; haptic dislocation) | |
| Eyes with no late IOl complication | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation)
Measured: 1997-2007 (retrospective)
Secondary outcomes (10)
Incidence rates for a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation)
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor pseudoexfoliation (PXF)
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor myopia.
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor uveitis.
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor retinitis pigmentosa.
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor age.
Measured: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor sex.
Measured: 1997-2007 (retrospective)
Time from cataract operation to late in-the-bag dislocation.
Measured: 1997-2007 (retrospective)
Time from cataract operation to late out-of-the-bag dislocation.
Measured: 1997-2007 (retrospective)
Time from cataract operation to late haptic bending.
Measured: 1997-2007 (retrospective)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Vienna Institute for Research in Ocular Surgery
- Responsible party
- Principal investigator, Mayer Christoph, MD, Medical University of Graz
- Investigators
- Christoph F Mayer, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747667
- Sponsor's protocol ID
- 26-066 ex 13/14
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Dislocation and Haptic Deformation of a Hydrophilic Intraocular Lens: Characteristics, Incidence Rates and Predisposing Factors
- ClinicalTrials.gov ID
- NCT02747667
- Acronym / sponsor ID
- 26-066 ex 13/14
- Conditions
- Complications
- Keywords
- iol dislocation, iol complication, intraocular lens, Implant or Graft, Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,125 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Vienna Institute for Research in Ocular Surgery
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then several case reports and case series were observed. In-the-bag IOL dislocation is a well-known postoperative complication, especially in eyes with weak zonules as seen in pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).
In this retrospective study, medical records of all patients with IOL related problems after implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and predisposing factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic complications will be investigated and compared amongst each other or control patients. Incidence rates for each IOL complication will be calculated. For in-the-bag dislocations odds ratios for each predisposing factor will be calculated.
Detailed description
This is a retrospective cohort study. Data of all patients treated at the hospital from June 1997 to October 2015 for a complication after IOL implantation will be obtained from an electronic medical record and database (FileMaker Inc., v3 - 6 and EyMed). Additional data, e.g. axial length (AL) or diopters of the implanted IOL, are taken from the patients' medical files. Collected data are age, sex, laterality of the eye, and predisposing eye conditions (PXF, relevant myopia defined as ≥ 25.5 mm axial length, uveitis, RP and ocular trauma). Other parameters are preoperative surgical interventions, the use of a capsular tension ring (CTR), perioperative complications, diopters of the IOL, pre- and postoperative corrected distance visual acuity (CDVA) in logMAR, and post-operative manifest refraction. Time to dislocation, additional interventions after cataract surgery, and symptoms due to the IOL complication will recorded. Type of dislocation (in-the-bag or out-of-the-bag), location (anterior chamber, pupillary plane or vitreous), pre- and post-operative CDVA, pre- and post-operative manifest refraction, type of secondary intervention, and in case secondary implantation was performed, type of secondary IOL are collected.
Differences regarding prevalence for various predisposing risk factors are investigated by means of logistic regression methods. Odds ratios and 95% confidence intervals are calculated unadjusted as well as adjusted for age, gender, and the four predisposing risk factors: PXF, relevant myopia, uveitis, and RP. Prevalence and incidence of in-the-bag IOL dislocations will be calculated from all patients that had an implantation of the ACR6D SE at the Department of Ophthalmology in Graz.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye with late IOL complication | – | –Alle patients with IOL complication (subgroup: in-the-bag dislocation; out-of-the-bag dislocation; haptic dislocation) |
| Eyes with no late IOl complication | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with phacoemulsification and extracapsular cataract surgery with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.
Key inclusion criteria (1 listed)
- Phacoemulsification or extracapsular cataract extraction with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.
Key exclusion criteria (1 listed)
- Intracapsular cataract extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation)
Time frame: 1997-2007 (retrospective)
10 secondary outcomes
Incidence rates for a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation)
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor pseudoexfoliation (PXF)
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor myopia.
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor uveitis.
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor retinitis pigmentosa.
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor age.
Time frame: 1997-2007 (retrospective)
Odds ratios for in-the-bag dislocations for predisposing risk factor sex.
Time frame: 1997-2007 (retrospective)
Time from cataract operation to late in-the-bag dislocation.
Time frame: 1997-2007 (retrospective)
Time from cataract operation to late out-of-the-bag dislocation.
Time frame: 1997-2007 (retrospective)
Time from cataract operation to late haptic bending.
Time frame: 1997-2007 (retrospective)
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 22 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Christoph F Mayer, MD principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
An observational study of Complications, run by Medical University of Graz.
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 1 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Occurrence of a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation) (time frame: 1997-2007 (retrospective)). 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 22 Apr 2016.