Comparison of the Capsular Stability With Two Different IOL Models in Patients With Pseudoexfoliation Syndrome: an Exploratory Study
1 other identifier
interventional
30
1 country
1
Brief Summary
The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular material in the anterior chamber of the eye as well as in other tissues of the body. Approx. 70 million worldwide have a PXF syndrome. After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens more frequently than in the general population due to a higher incidence of zonular weakness and an increased capsular fibrotic reaction. Decentration, tilt and / or rotation of the lens can reduce the quality of vision. It is believed that the design of the implanted IOL, more precisely the front surface of the IOL has an influence on the extent of capsular fibrosis and contraction. Especially in presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the design of the IOL has an effect on the post-operative stability. In this study, two different IOL models are compared in terms of their stability. The "Tecnis 1-piece ZCB00" (AMO, USA), with a concave lowering comprising the lens edge and the "Acrysof SA60AT" (Alcon, USA), with a biconvex design are compared. Forty eyes of 20 patients are planned to be included in this study. One eye receives the "Tecnis ZCB00 1-piece "(AMO, USA), while the other eye receives the"Acrysof SA60AT "(Alcon, USA). In which eye which IOL is implanted, is assigned by randomization. To measure the decentration, tilt and rotation of the IOL an examination will be performed before the operation and there will be follow-ups one hour after the operation of the first eye, one hour after the operation of the second eye, three months and twelve months after the operation on the second eye. All measurements will be done without touching the eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJune 4, 2014
June 1, 2014
2 years
June 2, 2014
June 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Difference between the two IOLS in postoperative IOL tilt (degrees) and decentration (mm) measured with the Purkinjemeter
12 months
Secondary Outcomes (5)
Horizontal and vertical IOL tilt (in °) evaluated from AS-OCT and Scheimpflug images
12 months
Change in rhexis diameter (mm in retroillumination foto)
12 months
Change in anterior chamber depth (in mm) measured with the AC Master
12 months
Subjective evaluation of IOL - anterior capsule interconnection ( capsule overlapping the IOL optic edge in slitlamp examination)
12 months
Change in aqueous flare measured with laser flare meter
12 months
Study Arms (2)
AMO ZCB00
OTHERAMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL
ISERT 250
ACTIVE COMPARATORISERT 250 (HOYA, Japan): a standard IOL
Interventions
Eligibility Criteria
You may qualify if:
- Age-related cataract
- Age 21 and older
- Pseudoexfoliation syndrome
- written informed consent prior to surgery
You may not qualify if:
- Relevant ophthalmic diseases that could affect corneal transparency or the ability for fixation of LEDs
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, Vienna, 1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl
ViROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prim. Prof. Dr. Oliver Findl, MBA
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 4, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 4, 2014
Record last verified: 2014-06