Health TrialsbyHealthPanel

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

ConditionsAge Related CataractsPseudoexfoliation Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 60 - 100

Necessity for bilateral cataract surgery with pseudoexfoliation syndrome

willing to give informed consent and follow-up the duration of study

Disqualifiers

Endstage glaucoma

Christalline lens sub/ luxation

active inflammatory diseases of the eye

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phakoemulsification

    Procedure/Surgery

    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.

  • Ziemer Z8 Femtolaser

    Device

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

  • Kowa Avansee Preset

    Device

    The used 3 piece intra ocular lens

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SulcusOther 3 interventions
Group B: In the bagOther 3 interventions

Trial outcomes

Primary outcomes

1

The change of lens tilt and decentration from baseline to month 60 postoperatively

The change of lens tilt and decentration from baseline to month 60 postoperatively, measured by anterior segment optical coherence tomography.

Time frame
Baseline to month 60 postoperatively
2

The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method.

The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method at month 60 post operatively, measured by anterior segment optical coherence tomography.

Time frame
Month 60 postoperatively

Secondary outcomes

1

Capsular phimoses

The amount of anterior capsular phimosis and rhexis shrinking, evaluated on anterior segment images.

Time frame
Month 60 postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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