CataractSLICESNCT02898909
Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery
A study testing nuclear lens fragmentation in 8 pieces and nuclear lens fragmentation in 16 pieces in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed. It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- nuclear lens fragmentation in 8 pieces and nuclear lens fragmentation in 16 pieces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to 10 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged ≥ 18 years old
- first Femtosecond Laser-assisted Cataract Surgery scheduled
- cataract density ≥ 3 according to the lens opacities classification system (LOCS)
Who cannot join
- corneal guttata, uncontrolled glaucoma
- shallow depth of anterior chamber
- patient's refusal to participate in the study
- pregnant or breast feeding patient
- patient under legal protection
- no health coverage
Trial locations and contacts
1 site in 1 country.
About this study
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.
It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.
The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.
- Conditions
- Cataract
- Being tested
- nuclear lens fragmentation in 8 pieces, nuclear lens fragmentation in 16 pieces
- Keywords
- femtosecond laser-assisted cataract surgery, nuclear lens fragmentation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nuclear lens fragmentation in 8 piecesDevice
nuclear lens fragmentation in 16 piecesDevice
| Study group | Role | What they receive |
|---|---|---|
| 16 pieces fragmentation | Experimental | Not described Receives: Device: nuclear lens fragmentation in 16 pieces |
| 8 pieces fragmentation | Active comparator | Not described Receives: Device: nuclear lens fragmentation in 8 pieces |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy delivered for lens nucleus aspiration during phacoemulsification
ultrasound power delivered (measured in Hertz)
Measured: approximatively 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start15 Nov 2016
- Primary completion21 Dec 2017
- Study completion10 Dec 2019
Why it stopped: Major inclusion difficulties
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FEBBRARO, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898909
- Sponsor's protocol ID
- JFO_2015_44
- Acronym
- SLICES
- Status last verified
- Dec 2019
- First submitted
- 8 Sep 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT02898909
- Acronym / sponsor ID
- SLICES / JFO_2015_44
- Conditions
- Cataract
- Keywords
- femtosecond laser-assisted cataract surgery, nuclear lens fragmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major inclusion difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.
It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.
The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16 pieces fragmentation | Experimental | Device: nuclear lens fragmentation in 16 pieces |
| 8 pieces fragmentation | Active comparator | Device: nuclear lens fragmentation in 8 pieces |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient aged ≥ 18 years old
- first Femtosecond Laser-assisted Cataract Surgery scheduled
- cataract density ≥ 3 according to the lens opacities classification system (LOCS)
Key exclusion criteria (6 listed)
- corneal guttata, uncontrolled glaucoma
- shallow depth of anterior chamber
- patient's refusal to participate in the study
- pregnant or breast feeding patient
- patient under legal protection
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 |
|---|---|---|
| nuclear lens fragmentation in 8 pieces | Device | 8 pieces fragmentation |
| nuclear lens fragmentation in 16 pieces | Device | 16 pieces fragmentation |
Primary outcome
energy delivered for lens nucleus aspiration during phacoemulsification
Time frame: approximatively 15 minutes
ultrasound power delivered (measured in Hertz)
Results and safety
The study was stopped early (reason given: Major inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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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.
Jean-Luc FEBBRARO, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nuclear lens fragmentation in 8 pieces and nuclear lens fragmentation in 16 pieces in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: Major inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy delivered for lens nucleus aspiration during phacoemulsification (time frame: approximatively 15 minutes). 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 12 Dec 2019.