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

NCT ID: NCT05271942

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization into two groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tilt and Tumble

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

Group Type EXPERIMENTAL

Tilt and Tumble

Intervention Type PROCEDURE

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

Divide and Conquer

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

Group Type ACTIVE_COMPARATOR

Divide and Conquer

Intervention Type PROCEDURE

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

Interventions

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Tilt and Tumble

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

Intervention Type PROCEDURE

Divide and Conquer

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cataract

Exclusion Criteria

* Dementia
* Very narrow anterior chamber
* Born after 1965
Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aleris Eye

INDUSTRY

Sponsor Role lead

Responsible Party

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Johan Ursberg

Chief Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aleris Eye Clinci

Helsingborg, Skåne County, Sweden

Site Status RECRUITING

Aleris Eye Clinic

Malmo, Skåne County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Johan Ursberg, MD

Role: CONTACT

0046704390781

Ida Ankar

Role: CONTACT

Facility Contacts

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Johan Ursberg, MD

Role: primary

0046704390781

Jessica Hammarbäck

Role: backup

Johan Ursberg, MD

Role: primary

+46704390781

Carina Svensson

Role: backup

Other Identifiers

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Aleris Eye

Identifier Type: -

Identifier Source: org_study_id

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