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

Study Overview
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Tilt and Tumble
* Procedure: Divide and Conquer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataract Exclusion Criteria: Dementia Very narrow anterior chamber Born after 1965

Ages Eligible for Study
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Minimum Age: 56 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tilt and Tumble<br>The patients of this group will undergo cataract surgery using the Tilt and Tumble technique. | Procedure: Tilt and Tumble<br>* The Tilt and Tumble technique is used to remove the human lens.<br>|
| Active Comparator: Divide and Conquer<br>The patients of this group will undergo cataract surgery using the Divide and Conquer technique. | Procedure: Divide and Conquer<br>* The Divide and Conquer technique is used to remove the human lens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Divide and Conquer, Tilt and Tumble