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

NCT06053554 | Recruiting DMC

• 1 other identifier: PEX-2305
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Femtolaser; Sulcus-IOL; Anterior segment; Lens tilt and decentration; Capsular phimoses

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to month 60 postoperatively

• 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.

  Month 60 postoperatively

Secondary Outcomes (1)

• Capsular phimoses

  Month 60 postoperatively

Study Arms (2)

Sulcus

OTHER

On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard.

Procedure: Phakoemulsification; Device: Ziemer Z8 Femtolaser; Device: Kowa Avansee Preset

In the bag

OTHER

On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard.

Procedure: Phakoemulsification; Device: Ziemer Z8 Femtolaser; Device: Kowa Avansee Preset

Interventions

Phakoemulsification PROCEDURE

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.

In the bag; Sulcus

Ziemer Z8 Femtolaser DEVICE

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

In the bag; Sulcus

Kowa Avansee Preset DEVICE

The used 3 piece intra ocular lens

In the bag; Sulcus

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 - 100
• Necessity for bilateral cataract surgery with pseudoexfoliation syndrome
• willing to give informed consent and follow-up the duration of study

You may not qualify if:

• Endstage glaucoma
• Christalline lens sub/ luxation
• active inflammatory diseases of the eye

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Exfoliation Syndrome

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Claudette ABELA-FORMANEK, Prof. Dr.

  Department for Ophthalmology and Optometry, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudette ABELA-FORMANEK, Prof.Dr.

CONTACT

+43(0)14040079680; claudette.abela-formanek@meduniwien.ac.at

Markus Schranz, Dr.

CONTACT

+43(0)14040079690; markus.schranz@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: September 25, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)