Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods

NCT05271942 | Unknown

• 1 other identifier: Aleris Eye
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.

Conditions

Cataract

Keywords

Divide and Conquer, Tilt and Tumble

Outcome Measures

Primary Outcomes (4)

• Differences in energy during phacoemulsification between the methods investigated.

  Energy used during phacoemulsification is measured during each surgery. It is measured with the unit Cumulative Dissipated Energy (CDE).

  Immediately after the surgery

• Differences in time used during phacoemulsification during surgery between the methods investigated

  Time, measured in seconds (s), will be measured from the start til the end of phacoemulsification

  Immediately after the intervention/procedure/surgery

• Difference in corneal endothelial cell density after cataract surgery between the study groups investigated. Before and after surgery. Change is being assessed.

  During cataract surgery the participants loose some of the endothelial cells. The investigator can measure endothelial cell density (CD) with an endothelial cell camera. This will be done before and after surgery in both study groups.

  Pre-intervention surgery and 14 days after surgery.

• Measurement of clinical och subclinical macular oedema before and after surgery. Change is being assessed.

  Clinical or subclinical macular oedema is a known complication to cataract surgery. Macula will be measured with an Ocular Coherence Tomography (OCT) before and after surgery. Retinal thickness in macula will be measured in micrometer. Data is collected after each surgery from the phaco apparatus throughout the study.

  Pre-intervention surgery and 14 days after surgery.

Study Arms (2)

Tilt and Tumble

EXPERIMENTAL

The patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique.

Procedure: Tilt and Tumble

Divide and Conquer

ACTIVE COMPARATOR

The patients of this group will undergo cataract surgery using the "Divide and Conquer" technique.

Procedure: Divide and Conquer

Interventions

Tilt and Tumble PROCEDURE

The Tilt and Tumble technique is used to remove the human lens.

Tilt and Tumble

Divide and Conquer PROCEDURE

The Divide and Conquer technique is used to remove the human lens.

Divide and Conquer

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract

You may not qualify if:

• Dementia
• Very narrow anterior chamber
• Born after 1965

Sponsors & Collaborators

• Aleris Eye: lead

Study Sites (2)

Aleris Eye Clinci

Helsingborg, Skåne County, 25225, Sweden

RECRUITING

Aleris Eye Clinic

Malmo, Skåne County, 21138, Sweden

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Johan Ursberg, MD

CONTACT

0046704390781; johan.ursberg@aleris.se

Ida Ankar

CONTACT

ida.ankar@aleris.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: Randomization into two groups

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: March 9, 2022
• Study Start: September 8, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2023

Locations

SE (2)