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Characteristics and Risk Ratios of Late Intraocular Lens (IOL) Complication

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ClinicalTrials.gov Identifier: NCT02747667
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Vienna Institute for Research in Ocular Surgery
Information provided by (Responsible Party):
Mayer Christoph, MD, Medical University of Graz

Brief 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. 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.


Condition or disease
Complications

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.


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Study Type : Observational
Actual Enrollment : 10125 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Late Dislocation and Haptic Deformation of a Hydrophilic Intraocular Lens: Characteristics, Incidence Rates and Predisposing Factors
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Group/Cohort
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



Primary Outcome Measures :
  1. Occurrence of a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation) [ Time Frame: 1997-2007 (retrospective) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Odds ratios for in-the-bag dislocations for predisposing risk factor pseudoexfoliation (PXF) [ Time Frame: 1997-2007 (retrospective) ]
  3. Odds ratios for in-the-bag dislocations for predisposing risk factor myopia. [ Time Frame: 1997-2007 (retrospective) ]
  4. Odds ratios for in-the-bag dislocations for predisposing risk factor uveitis. [ Time Frame: 1997-2007 (retrospective) ]
  5. Odds ratios for in-the-bag dislocations for predisposing risk factor retinitis pigmentosa. [ Time Frame: 1997-2007 (retrospective) ]
  6. Odds ratios for in-the-bag dislocations for predisposing risk factor age. [ Time Frame: 1997-2007 (retrospective) ]
  7. Odds ratios for in-the-bag dislocations for predisposing risk factor sex. [ Time Frame: 1997-2007 (retrospective) ]
  8. Time from cataract operation to late in-the-bag dislocation. [ Time Frame: 1997-2007 (retrospective) ]
  9. Time from cataract operation to late out-of-the-bag dislocation. [ Time Frame: 1997-2007 (retrospective) ]
  10. Time from cataract operation to late haptic bending. [ Time Frame: 1997-2007 (retrospective) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Phacoemulsification or extracapsular cataract extraction with the hydrophilic acrylic IOL ACR6D SE at the Department of Ophthalmology Graz in Styria, Austria.

Exclusion Criteria:

  • Intracapsular cataract extraction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747667


Sponsors and Collaborators
Medical University of Graz
Vienna Institute for Research in Ocular Surgery
Investigators
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Principal Investigator: Christoph F Mayer, MD Medical University of Graz

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Responsible Party: Mayer Christoph, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT02747667     History of Changes
Other Study ID Numbers: 26-066 ex 13/14
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mayer Christoph, MD, Medical University of Graz:
iol dislocation
iol complication
intraocular lens
Implant or Graft
Eye