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

• Sponsor: Aleris Eye (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05271942
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 26.7
• Patients Per Site: 500
• Patients Per Site Per Month: 18.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Tilt and Tumble; Procedure: Divide and Conquer	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomization into two groupsRandomization into two groups
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
• Actual Study Start Date: Sep 8, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Differences in energy during phacoemulsification between the methods investigated. [Immediately after the surgery]

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

2. Differences in time used during phacoemulsification during surgery between the methods investigated [Immediately after the intervention/procedure/surgery]

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

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cataract

Exclusion Criteria:

• Dementia

• Very narrow anterior chamber

• Born after 1965

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aleris Eye Clinci	Helsingborg	Skåne	Sweden	25225
2	Aleris Eye Clinic	Malmö	Skåne	Sweden	21138

Sponsors and Collaborators

• Aleris Eye

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johan Ursberg, Chief Medical Officer, Aleris Eye
• ClinicalTrials.gov Identifier: NCT05271942
• Other Study ID Numbers: Aleris Eye
• First Posted: Mar 9, 2022
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johan Ursberg, Chief Medical Officer, Aleris Eye: Divide and Conquer, Tilt and Tumble
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Mar 9, 2022