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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271942
• Other study ID #: Aleris Eye
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Aleris Eye
• Contact: Johan Ursberg, MD
• Phone: 0046704390781
• Email: johan.ursberg[@]aleris.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years and older

Eligibility

Inclusion Criteria:

• Cataract

Exclusion Criteria:

• Dementia

• Very narrow anterior chamber

• Born after 1965

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Tilt and Tumble
The Tilt and Tumble technique is used to remove the human lens.
• Divide and Conquer
The Divide and Conquer technique is used to remove the human lens.

Locations

Country	Name	City	State
Sweden	Aleris Eye Clinci	Helsingborg	Skåne
Sweden	Aleris Eye Clinic	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Aleris Eye

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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.