Cataract
Conditions
Keywords
Divide and Conquer, Tilt and Tumble
Brief summary
The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.
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.
Interventions
PROCEDURETilt and Tumble
The Tilt and Tumble technique is used to remove the human lens.
PROCEDUREDivide and Conquer
The Divide and Conquer technique is used to remove the human lens.
Sponsors
Aleris Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Randomization into two groups
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cataract
Exclusion criteria
* Dementia * Very narrow anterior chamber * Born after 1965
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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. |
| 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. |
Countries
Sweden
Contacts
Primary ContactJohan Ursberg, MD
Backup ContactIda Ankar
Outcome results
None listed