Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06053554
Other study ID # PEX-2305
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date August 2030

Study information

Verified date October 2023
Source Medical University of Vienna
Contact Claudette ABELA-FORMANEK, Prof.Dr.
Phone +43(0)14040079680
Email claudette.abela-formanek@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 2030
Est. primary completion date May 2030
Accepts healthy volunteers No
Gender All
Age group 60 Years to 100 Years
Eligibility 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 Design


Intervention

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.
Kowa Avansee Preset
The used 3 piece intra ocular lens

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Capsular phimoses The amount of anterior capsular phimosis and rhexis shrinking, evaluated on anterior segment images. Month 60 postoperatively
See also
  Status Clinical Trial Phase
Completed NCT00121147 - Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan N/A
Enrolling by invitation NCT04590651 - Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma N/A
Not yet recruiting NCT04274634 - The Oscillation of Crystalline and Intraocular Lenses
Not yet recruiting NCT03265457 - The Endothelial Count in Pxf
Completed NCT02137161 - Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery Phase 4
Completed NCT06423079 - Scleral Fixation for Intraocular Lens-Bag Dislocation
Completed NCT06121154 - Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
Terminated NCT00690222 - Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery N/A
Completed NCT05447130 - Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome N/A
Completed NCT00327613 - Plasma Levels of Matrix Metalloproteinases (MMPs) and Degree of DNA Fragmentation in Pseudoexfoliation (PEX) Glaucoma N/A
Recruiting NCT05156138 - The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes
Completed NCT01298895 - Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome N/A
Recruiting NCT01515735 - LOXL1 Polymorphism in Pseudoexfoliation Syndrome N/A
Terminated NCT00546013 - Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome N/A
Completed NCT05113121 - Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome
Completed NCT01767012 - Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties Phase 4
Completed NCT03453827 - Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery N/A