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

NCT02747667 | Completed

• 1 other identifier: 26-066 ex 13/14
• Study Type: observational
• Target: 10,125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complications

Keywords

iol dislocation; iol complication; intraocular lens; Implant or Graft; Eye

Outcome Measures

Primary Outcomes (1)

• Occurrence of a late IOL complication (in-the-bag dislocation, out-of-the-bag dislocation and haptic bag dislocation)

  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)

  1997-2007 (retrospective)

• Odds ratios for in-the-bag dislocations for predisposing risk factor pseudoexfoliation (PXF)

  1997-2007 (retrospective)

• Odds ratios for in-the-bag dislocations for predisposing risk factor myopia.

  1997-2007 (retrospective)

• Odds ratios for in-the-bag dislocations for predisposing risk factor uveitis.

  1997-2007 (retrospective)

• Odds ratios for in-the-bag dislocations for predisposing risk factor retinitis pigmentosa.

  1997-2007 (retrospective)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Intracapsular cataract extraction

Sponsors & Collaborators

• Medical University of Graz: lead
• Vienna Institute for Research in Ocular Surgery: collaborator

Study Officials

• Christoph F Mayer, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 22, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share