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Comparison of the Capsular Stability With Two Different IOL Models in Patients With Pseudoexfoliation Syndrome: an Exploratory Study

NCT02155478 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-06-04

No results posted yet for this study

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.

Conditions

  • Cataract

Interventions

DEVICE

ISERT 250 (HOYA, Japan): a standard IOL

DEVICE

AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL

Sponsors & Collaborators

  • Vienna Institute for Research in Ocular Surgery

    lead OTHER

Principal Investigators

  • Oliver Findl · ViROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155478 on ClinicalTrials.gov