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

February 28, 2022 updated by: Johan Ursberg, Aleris Eye
The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all participants who have signed the written informed consent will be randomized to undergo cataract surgery with either the method called "Divide and Conquer" or "Tilt and Tumble". Pre- per- and postoperative measurements from the surgery will be filed and compared later on by the investigator.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Dementia
  • Very narrow anterior chamber
  • Born after 1965

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tilt and Tumble
The patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique.
Procedure: Tilt and Tumble
The Tilt and Tumble technique is used to remove the human lens.
ACTIVE_COMPARATOR: Divide and Conquer
The patients of this group will undergo cataract surgery using the "Divide and Conquer" technique.
Procedure: Divide and Conquer
The Divide and Conquer technique is used to remove the human lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in energy during phacoemulsification between the methods investigated.
Time Frame: Immediately after the surgery
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 Frame: Immediately after the intervention/procedure/surgery
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.
Time Frame: Pre-intervention surgery and 14 days after surgery.
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.
Time Frame: Pre-intervention surgery and 14 days after surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aleris Eye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 8, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

February 28, 2022

First Posted (ACTUAL)

March 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aleris Eye

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2023

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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