CataractNCT05271942
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
A study testing Tilt and Tumble and Divide and Conquer in people with Cataract, run by Aleris Eye at 2 sites in Sweden.
Trial summary
The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Tilt and Tumble and Divide and Conquer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesSweden
- Study dates
- 8 Sep 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
Who cannot join
- Dementia
- Very narrow anterior chamber
- Born after 1965
Trial locations and contacts
2 sites in 1 country.
Ida Ankar contact
Sweden2 sites, 2 recruiting
- Recruiting
Aleris Eye Clinci
Helsingborg, Skåne County, 25225
Johan Ursberg, MD, 0046704390781, johan.ursberg@aleris.se
Jessica Hammarbäck, jessica.hammarback@aleris.se
- Recruiting
Aleris Eye Clinic
Malmö, Skåne County, 21138
Johan Ursberg, MD, +46704390781, johan.ursberg@aleris.se
Carina Svensson, carina.svensson@aleris.se
About this study
The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.
Read the 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.
- Conditions
- Cataract
- Being tested
- Tilt and Tumble, Divide and Conquer
- Keywords
- Divide and Conquer, Tilt and Tumble
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilt and TumbleProcedure or surgery
The Tilt and Tumble technique is used to remove the human lens.
Divide and ConquerProcedure or surgery
The Divide and Conquer technique is used to remove the human lens.
| Study group | Role | What they receive |
|---|---|---|
| Tilt and Tumble | Experimental | The patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique. Receives: Procedure: Tilt and Tumble |
| Divide and Conquer | Active comparator | The patients of this group will undergo cataract surgery using the "Divide and Conquer" technique. Receives: Procedure: Divide and Conquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre-intervention surgery and 14 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start8 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into two groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleris Eye
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Johan Ursberg, Aleris Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271942
- Sponsor's protocol ID
- Aleris Eye
- Status last verified
- Feb 2022
- First submitted
- 15 Sep 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
- ClinicalTrials.gov ID
- NCT05271942
- Acronym / sponsor ID
- Aleris Eye
- Conditions
- Cataract
- Keywords
- Divide and Conquer, Tilt and Tumble
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Aleris EyeIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization into two groups
| Arm | Type | Receives |
|---|---|---|
| Tilt and Tumble | Experimental | Procedure: Tilt and TumbleThe patients of this group will undergo cataract surgery using the "Tilt and Tumble" technique. |
| Divide and Conquer | Active comparator | Procedure: Divide and ConquerThe patients of this group will undergo cataract surgery using the "Divide and Conquer" technique. |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cataract
Key exclusion criteria (3 listed)
- Dementia
- Very narrow anterior chamber
- Born after 1965
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tilt and TumbleThe Tilt and Tumble technique is used to remove the human lens. | Procedure or surgery | Tilt and Tumble |
| Divide and ConquerThe Divide and Conquer technique is used to remove the human lens. | Procedure or surgery | Divide and Conquer |
Primary outcome
Differences in energy during phacoemulsification between the methods investigated.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida Ankar contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tilt and Tumble and Divide and Conquer in people with Cataract, run by Aleris Eye at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Ursberg, MD (0046704390781, johan.ursberg@aleris.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in energy during phacoemulsification between the methods investigated. (time frame: Immediately after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.