MedTrace Logo

Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome

NCT06053554 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-24

No results posted yet for this study

Summary

The aim of this study is to compare the surgical outcomes of the two IOL implantation methods for eyes with cataract and PEX in a single-center and with highly experienced surgeons. The goal is to acquire relevant information regarding these two IOL implantation techniques, which will help surgeons to decide which approach to choose, ultimately resulting in a benefit for patients with PEX syndrome who require cataract surgery.

The main questions are:

Is there a difference in lens tilt and decentration between the both methods. Is there a difference in the frequency and amount of capsular phimosis between the both methods.

Conditions

  • Age Related Cataracts
  • Pseudoexfoliation Syndrome

Interventions

PROCEDURE

Phakoemulsification

Femtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus toguarantee reproducible results in every eye.After the CCC and nucleus fragmentation the anterior segment is filled with viscoelastics, the rhexis lenticule is removed and hydrodisection of the nucleus is performed. Subsequently phacoemulsification for nucleus and irrigation/aspiration of the lens cortex is performed. The capsular bag and AC is then filled with a cohesive viscoelastic and the IOL is implanted with the haptics in the back or with the haptics in the sulcus. At the end of surgery, the viscoelastic is removed using the irrigation aspiration probe, intracameral antibiotic is instilled, the CCI and paracenteses are hydrated and sealed.

DEVICE

Ziemer Z8 Femtolaser

The femto second laser used for certain steps (capsulorhexis, nucleus fragmentation) of the cataract surgery.

DEVICE

Kowa Avansee Preset

The used 3 piece intra ocular lens

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Claudette ABELA-FORMANEK, Prof. Dr. · Department for Ophthalmology and Optometry, Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2030-05-31
Completion
2030-08-31

Countries

  • Austria

Study Locations

More Related Trials

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 NCT06053554 on ClinicalTrials.gov