Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery

Nuclear Cataract Clinical Trial

Official title:

Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736042
• Other study ID #: OZR-2022-07
• Secondary ID: NL83139.078.22
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Oogziekenhuis Rotterdam
• Contact: Rene Wubbels
• Phone: +31104023430
• Email: r.wubbels[@]oogziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.

Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.

Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Informed consent.

• Advanced visually significant nuclear sclerosis grade = 5 (LOCS III).

Exclusion Criteria:

• Endothelial cell density (ECD) < 1500 mm-2.

• Corneal opacification (any cause).

• Corneal surgery or trauma.

• Implant lens.

• Refraction surgery.

• Prior glaucoma surgery.

• Pseudoexfoliation.

Related Conditions & MeSH terms

• Cataract
• Nuclear Cataract

Intervention

Device:
• Lens fragmentation
Lens fragmentation with the microinterventional microfilament loop device (miLOOP)

Locations

Country	Name	City	State
Netherlands	Oogziekenhuis Rotterdam	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Oogziekenhuis Rotterdam	Carl Zeiss Meditec AG, Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound cumulative dispersed energy (CDE)	Phaco energy (Centurion, Alcon)	During surgery
Primary	Change of corneal endothelial cell density (ECD)	Central cell density will be assessed	Preoperative and at 3 months
Secondary	Procedure time	Total sugery time	During surgery
Secondary	Peri-operative complications	Any complications during surgery	During surgery
Secondary	Postoperative complications	Any complications after surgery	Up to 3 months