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

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tilt and Tumble
Divide and Conquer
Sponsored by
Aleris Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Divide and Conquer, Tilt and Tumble

Eligibility Criteria

56 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Dementia
  • Very narrow anterior chamber
  • Born after 1965

Sites / Locations

  • Aleris Eye ClinciRecruiting
  • Aleris Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tilt and Tumble

Divide and Conquer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
February 28, 2022
Sponsor
Aleris Eye
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1. Study Identification

Unique Protocol Identification Number
NCT05271942
Brief Title
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
Official Title
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aleris Eye

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Divide and Conquer, Tilt and Tumble

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization into two groups
Masking
Investigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tilt and Tumble
Arm Type
Experimental
Arm Description
The patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique.
Arm Title
Divide and Conquer
Arm Type
Active Comparator
Arm Description
The patients of this group will undergo cataract surgery using the "Divide and Conquer" technique.
Intervention Type
Procedure
Intervention Name(s)
Tilt and Tumble
Intervention Description
The Tilt and Tumble technique is used to remove the human lens.
Intervention Type
Procedure
Intervention Name(s)
Divide and Conquer
Intervention Description
The Divide and Conquer technique is used to remove the human lens.
Primary Outcome Measure Information:
Title
Differences in energy during phacoemulsification between the methods investigated.
Description
Energy used during phacoemulsification is measured during each surgery. It is measured with the unit Cumulative Dissipated Energy (CDE).
Time Frame
Immediately after the surgery
Title
Differences in time used during phacoemulsification during surgery between the methods investigated
Description
Time, measured in seconds (s), will be measured from the start til the end of phacoemulsification
Time Frame
Immediately after the intervention/procedure/surgery
Title
Difference in corneal endothelial cell density after cataract surgery between the study groups investigated. Before and after surgery. Change is being assessed.
Description
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.
Time Frame
Pre-intervention surgery and 14 days after surgery.
Title
Measurement of clinical och subclinical macular oedema before and after surgery. Change is being assessed.
Description
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.
Time Frame
Pre-intervention surgery and 14 days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cataract Exclusion Criteria: Dementia Very narrow anterior chamber Born after 1965
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Ursberg, MD
Phone
0046704390781
Email
johan.ursberg@aleris.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ida Ankar
Email
ida.ankar@aleris.se
Facility Information:
Facility Name
Aleris Eye Clinci
City
Helsingborg
State/Province
Skåne
ZIP/Postal Code
25225
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Ursberg, MD
Phone
0046704390781
Email
johan.ursberg@aleris.se
First Name & Middle Initial & Last Name & Degree
Jessica Hammarbäck
Email
jessica.hammarback@aleris.se
Facility Name
Aleris Eye Clinic
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21138
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Ursberg, MD
Phone
+46704390781
Email
johan.ursberg@aleris.se
First Name & Middle Initial & Last Name & Degree
Carina Svensson
Email
carina.svensson@aleris.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
2023

Learn more about this trial

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

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