CataractPhase 4NCT02843594
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
A Phase 4 study testing LEEP intervention in people with Cataract, run by Iantech, Inc at 1 site in Panama.
Trial summary
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- LEEP intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 sitePanama
- Study dates
- Aug 2016to Sep 2018
- Phase
- Phase 4
- 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
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
- Subjects with a visually significant cataract scheduled to undergo cataract surgery
- Subjects > 18 years of age
- BCVA at baseline not better than 20/40
- Grade 1+ cataracts
Who cannot join
- Subjects not able to complete the informed consent form
- Subjects < 18 years of age
- Polar cataracts
- Zonular instability
Trial locations and contacts
1 site in 1 country.
Panama1 site, 1 recruiting
- Recruiting
Clinica de Ojos Panama City
Panama City
Ernesto Calvo, MD, (305) 898-0472, ecalvo86@mac.com
About this study
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.
- Conditions
- Cataract
- Being tested
- LEEP intervention, Standard Phaco Control
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEEP interventionProcedure or surgery
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
Standard Phaco ControlProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LEEP Intervention C1 | Active comparator | Cataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1) Receives: Procedure: LEEP intervention |
| LEEP Intervention C2 | Active comparator | Cataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2) Receives: Procedure: LEEP intervention |
| Control Phaco C2 | Placebo comparator | Cataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2) Receives: Procedure: Standard Phaco Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Dispersed Phaco energy
Total phaco power and energy used as recorded by the phaco machine
Measured: Intraoperative
Secondary outcomes (1)
Endothelial cell loss
Change from baseline endothelial cell density as measured by specular microscopy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iantech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843594
- Sponsor's protocol ID
- LEEP103
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.
PubMed 29669780
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT02843594
- Acronym / sponsor ID
- LEEP103
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Iantech, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Jul 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.
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LEEP Intervention C1 | Active comparator | Procedure: LEEP interventionCataract surgery with micro-interventional LEEP technology lens fragmentation (non-randomized cohort 1) |
| LEEP Intervention C2 | Active comparator | Procedure: LEEP interventionCataract surgery with micro-interventional LEEP technology lens fragmentation (randomized cohort 2) |
| Control Phaco C2 | Placebo comparator | Procedure: Standard Phaco ControlCataract surgery with conventional phaco-assisted lens fragmentation (randomized cohort 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
- Subjects with a visually significant cataract scheduled to undergo cataract surgery
- Subjects > 18 years of age
- BCVA at baseline not better than 20/40
- Grade 1+ cataracts
Key exclusion criteria (4 listed)
- Subjects not able to complete the informed consent form
- Subjects < 18 years of age
- Polar cataracts
- Zonular instability
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 |
|---|---|---|
| LEEP interventionLow Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation | Procedure or surgery | LEEP Intervention C1, LEEP Intervention C2 |
| Standard Phaco Control | Procedure or surgery | Control Phaco C2 |
Primary outcome
Cumulative Dispersed Phaco energy
Time frame: Intraoperative
Total phaco power and energy used as recorded by the phaco machine
1 secondary outcome
Endothelial cell loss
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Derived from this study: PubMed 29669780Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LEEP intervention in people with Cataract, run by Iantech, Inc at 1 site in Panama.
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 5 inclusion and 4 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 24 Aug 2016. 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 Panama. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jennifer Gaines (+1 (415) 295-4770, admin@iantechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Dispersed Phaco energy (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843594, which also lists 1 linked publication.
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 24 Aug 2016.