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

Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome: Lens in the Bag-technique Versus Lens in the Ciliary Sulcus With Optic Capture Technique

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.

Study Overview

• Status: Recruiting
• Conditions: Pseudoexfoliation Syndrome; Age Related Cataracts
• Intervention / Treatment: Procedure: Phakoemulsification; Device: Ziemer Z8 Femtolaser; Device: Kowa Avansee Preset

Detailed Description

This is a prospective, intraindividual comparative study of two routinely used surgical techniques for IOL implantation in extracapsular cataract surgery. 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. Until the point of IOL implantation the surgery is identical in both methods and the surgeon is blinded.

Femtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus to guarantee reproducible results in every eye. In case of an insufficient pupil size (smaller than 5.5mm), 2.4mm clear corneal incision and paracenteses are performed prior to laser docking and a pupil expansion device is implanted under anterior segment filling with viscoelastic to enlarge the pupil diameter. 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 as described above 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.

Study investigators are blinded, however the selected method can be visible during the routinely performed slit-lamp examinations. During all evaluation and measuring processes (Evaluation of decentration, tilt, capsular phimoses, surgery time) the investigators are blinded. This study is performed by highly experienced surgeons, who have already performed both methods on a routine basis.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudette ABELA-FORMANEK, Prof.Dr.; Phone Number: +43(0)14040079680; Email: claudette.abela-formanek@meduniwien.ac.at
• Study Contact Backup: Name: Markus Schranz, Dr.; Phone Number: +43(0)14040079690; Email: markus.schranz@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Markus Schranz, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sulcus; 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; 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
Other: In the bag; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capsular phimoses	The amount of anterior capsular phimosis and rhexis shrinking, evaluated on anterior segment images.	Month 60 postoperatively

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Claudette ABELA-FORMANEK, Prof. Dr., Department for Ophthalmology and Optometry, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Femtolaser; Anterior segment; Sulcus-IOL; Lens tilt and decentration; Capsular phimoses
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Uveal Diseases; Lens Diseases; Iris Diseases; Syndrome; Cataract; Exfoliation Syndrome
• Other Study ID Numbers: PEX-2305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publications in peer reviewed journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No