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

Primary Purpose

Age Related Cataracts, Pseudoexfoliation Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Phakoemulsification
Ziemer Z8 Femtolaser
Kowa Avansee Preset
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Cataracts focused on measuring Femtolaser, Sulcus-IOL, Anterior segment, Lens tilt and decentration, Capsular phimoses

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sulcus

In the bag

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2023
Last Updated
October 20, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT06053554
Brief Title
Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
May 2030 (Anticipated)
Study Completion Date
August 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts, Pseudoexfoliation Syndrome
Keywords
Femtolaser, Sulcus-IOL, Anterior segment, Lens tilt and decentration, Capsular phimoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sulcus
Arm Type
Other
Arm Description
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.
Arm Title
In the bag
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Phakoemulsification
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ziemer Z8 Femtolaser
Intervention Description
The femto second laser used for certain steps (capsulorhexis, nucleus fragmentation) of the cataract surgery.
Intervention Type
Device
Intervention Name(s)
Kowa Avansee Preset
Intervention Description
The used 3 piece intra ocular lens
Primary Outcome Measure Information:
Title
The change of lens tilt and decentration from baseline to month 60 postoperatively
Description
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
Title
The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method.
Description
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 Outcome Measure Information:
Title
Capsular phimoses
Description
The amount of anterior capsular phimosis and rhexis shrinking, evaluated on anterior segment images.
Time Frame
Month 60 postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudette ABELA-FORMANEK, Prof.Dr.
Phone
+43(0)14040079680
Email
claudette.abela-formanek@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schranz, Dr.
Phone
+43(0)14040079690
Email
markus.schranz@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudette ABELA-FORMANEK, Prof. Dr.
Organizational Affiliation
Department for Ophthalmology and Optometry, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Schranz, Md

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Publications in peer reviewed journals

Learn more about this trial

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

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