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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilt and Tumble | Experimental | The patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique. |
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| Divide and Conquer | Active Comparator | The patients of this group will undergo cataract surgery using the "Divide and Conquer" technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilt and Tumble | Procedure | The Tilt and Tumble technique is used to remove the human lens. |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Ursberg, MD | Contact | 0046704390781 | johan.ursberg@aleris.se | |
| Ida Ankar | Contact | ida.ankar@aleris.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris Eye Clinci | Recruiting | Helsingborg | Skåne County | 25225 | Sweden |
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2023
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Randomization into two groups
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| Divide and Conquer | Procedure | The Divide and Conquer technique is used to remove the human lens. |
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| Aleris Eye Clinic | Recruiting | Malmö | Skåne County | 21138 | Sweden |
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