CataractNCT02466256
Intra and Postoperative Outcomes With 3 Injectors
A study testing Intraocular lens implantation, Autosert Injector and Royale Injector in people with Cataract, run by Iladevi Cataract and IOL Research Center.
Trial summary
This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors : Manual… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular lens implantation, Autosert Injector and Royale Injector
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 2014
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
- Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)
Who cannot join
- Glaucoma,
- uveitis,
- shallow anterior chamber (depth <2.1mm),
- prior ocular trauma or surgery,
- maximal pupillary dilatation <6mm,
- high myopia (axial length >25mm),
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- posterior polar cataracts,
- dense cataracts, and
- an IOL power <19.0 D or >25.0 D
About this study
Official title: Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors :
Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.
Read the detailed description
In this randomized, clinical trial, three types of injectors were compared :
- Manual, screw type injector (Monarch III)
- Manual, plunger type injector (Royale, ASICO)
- Motorized injector (Autosert, Alcon)
Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.
The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.
further, the surgeon was asked to subjectively grade the ease of implantation with each injector
- Conditions
- Cataract
- Being tested
- Intraocular lens implantation, Autosert Injector, Royale Injector, Monarch III Injector
- Keywords
- Intraocular lens implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lens implantationProcedure or surgery
Intraocular lens implantation
Autosert InjectorDevice
Motorised injection device for intraocular lens implantation
Royale InjectorDevice
Manual, plunger type injection device for intraocular lens implantation
Monarch III InjectorDevice
Manual, screw type injection device for intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Autosert Group | Placebo comparator | Procedure / Surgery : Intraocular lens implantation with Autosert injector Receives: Procedure: Intraocular lens implantation; Device: Autosert Injector |
| Royale Group | Placebo comparator | Procedure / Surgery : Intraocular lens implantation with Royale Injector Receives: Procedure: Intraocular lens implantation; Device: Royale Injector |
| Monarch III Injector | Placebo comparator | Procedure / Surgery : Intraocular lens implantation with Monarch III group Receives: Device: Monarch III Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision enlargement in mm
Measured: 1 minute after surgery
Secondary outcomes (2)
Trypan Blue ingress into the anterior chamber in log units
Measured: 1 minute after surgery
Incision morphology - qualitative
Measured: 1 day, 1 week and 1 month 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 Jun 2015 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
- Investigators
- abhay r vasavada, ms, frcs, Principal investigator, iladevi cataract & iol research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466256
- Sponsor's protocol ID
- 2014-005
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT02466256
- Acronym / sponsor ID
- 2014-005
- Conditions
- Cataract
- Keywords
- Intraocular lens implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Jun 2015 (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.
This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors :
Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.
Detailed description
In this randomized, clinical trial, three types of injectors were compared :
- Manual, screw type injector (Monarch III)
- Manual, plunger type injector (Royale, ASICO)
- Motorized injector (Autosert, Alcon)
Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.
The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.
further, the surgeon was asked to subjectively grade the ease of implantation with each injector
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autosert Group | Placebo comparator | Procedure: Intraocular lens implantation, Device: Autosert InjectorProcedure / Surgery : Intraocular lens implantation with Autosert injector |
| Royale Group | Placebo comparator | Procedure: Intraocular lens implantation, Device: Royale InjectorProcedure / Surgery : Intraocular lens implantation with Royale Injector |
| Monarch III Injector | Placebo comparator | Device: Monarch III InjectorProcedure / Surgery : Intraocular lens implantation with Monarch III group |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
- Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)
Key exclusion criteria (9 listed)
- Glaucoma,
- uveitis,
- shallow anterior chamber (depth <2.1mm),
- prior ocular trauma or surgery,
- maximal pupillary dilatation <6mm,
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 |
|---|---|---|
| Intraocular lens implantationIntraocular lens implantation | Procedure or surgery | Autosert Group, Royale Group |
| Autosert InjectorMotorised injection device for intraocular lens implantation | Device | Autosert Group |
| Royale InjectorManual, plunger type injection device for intraocular lens implantation | Device | Royale Group |
| Monarch III InjectorManual, screw type injection device for intraocular lens implantation | Device | Monarch III Injector |
Primary outcome
Incision enlargement in mm
Time frame: 1 minute after surgery
2 secondary outcomes
Trypan Blue ingress into the anterior chamber in log units
Time frame: 1 minute after surgery
Incision morphology - qualitative
Time frame: 1 day, 1 week and 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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.
abhay r vasavada, ms, frcs principal investigator
iladevi cataract & iol research centre
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens implantation, Autosert Injector and Royale Injector in people with Cataract, run by Iladevi Cataract and IOL Research Center.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incision enlargement in mm (time frame: 1 minute after surgery). 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 Jun 2015.