Eye DiseasePhase 1NCT01396967
Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery
A Phase 1 study testing surgery in people with Eye Disease and Cataract, run by Ziv Hospital at 1 site in Israel.
Trial summary
During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens. The capsulorhexis must be round and with regular edge and no tears. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Disease, Cataract
- What is being tested?
- surgery
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 1
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- senile cataract
Who cannot join
- dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency of a New Device for Performing Capsulorhexis in Cataract Surgery
During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens.
The capsulorhexis must be round and with regular edge and no tears. While performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens.
Read more
The round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens.
Today capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve is relatively long and difficult.
The proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. The learning curve is short and easy. The capsulorhexis is done through the original operating wound with no need to widen it.
Read the detailed description
Planed Procedure
20 patients will be tested in this trail.
Consecutive patients that have senile cataract will be examined preoperatively as is done usually and the data of the examination will be collected/ a special attention will be given to the type of cataract and lens stability.
Systemic diseases will not be considered as exclusion criteria.
Patients with dens or mature cataract will be excluded.
Patients will be explained about the new device and those who will agree will sign a consent form.
During the cataract surgery all steps will be done as usually except of the capsulorhexis which will be done by using the new device.
The capsulorhexis will be photographed for further evaluation by a microscope camera.
After the operation the surgeon will record his impression about the convenience of using the new device, the shape and form of the capsulorhexis and its stability and any other relevant information.
Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation. The results of those examinations will be recorded and collected with special attention of IOL stability, the shape of capsulorhexis and intra ocular post operative inflammation if will occur.
The data, including the surgeons' comments, shape and form of capsulorhexis IOL stability and the rest will be collected and processed.
In case in which the use of the device will not perform a round and regular capsulorhexis, or instability of the capsule will occur or a un predicted intraocular inflammation will be seen the trail will be stopped immediately
- Conditions
- Eye Disease, Cataract
- Being tested
- surgery
- Keywords
- capsulorhexis
- Medical subject headings
- Eye Diseases, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryDevice
Also called V.R.hexis-1
cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
capsulorhexis must be round and with regular edge and no tears
As the title of this experiment:"The trying a new device for performing capsulorhexis in cataract surgery".Becuase we are not changing the protocol of Cataract surgery,the outcome measure of this experiment is the efficiency of this device, the safety and the simplicity of the use the device inorder to give a simple and safe solution for capsulorhexis.Therefor the outcome measure will be IOL stability, the shape of capsulorexis and intra ocular post operative inflammation if will occur. The trail is not comparative.
Measured: Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseaseStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Joseph Pikkel, Md, Principal investigator, Ziv Medical Center Sefat Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396967
- Sponsor's protocol ID
- ZIV-0065-10
- Status last verified
- Aug 2011
- First submitted
- 13 Jul 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of a New Device for Performing Capsulorhexis in Cataract Surgery
- ClinicalTrials.gov ID
- NCT01396967
- Acronym / sponsor ID
- ZIV-0065-10
- Conditions
- Eye Disease, Cataract
- Keywords
- capsulorhexis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Jul 2011 (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.
During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens.
The capsulorhexis must be round and with regular edge and no tears. While performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens.
The round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens.
Today capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve is relatively long and difficult.
The proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. The learning curve is short and easy. The capsulorhexis is done through the original operating wound with no need to widen it.
Detailed description
Planed Procedure
20 patients will be tested in this trail.
Consecutive patients that have senile cataract will be examined preoperatively as is done usually and the data of the examination will be collected/ a special attention will be given to the type of cataract and lens stability.
Systemic diseases will not be considered as exclusion criteria.
Patients with dens or mature cataract will be excluded.
Patients will be explained about the new device and those who will agree will sign a consent form.
During the cataract surgery all steps will be done as usually except of the capsulorhexis which will be done by using the new device.
The capsulorhexis will be photographed for further evaluation by a microscope camera.
After the operation the surgeon will record his impression about the convenience of using the new device, the shape and form of the capsulorhexis and its stability and any other relevant information.
Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation. The results of those examinations will be recorded and collected with special attention of IOL stability, the shape of capsulorhexis and intra ocular post operative inflammation if will occur.
The data, including the surgeons' comments, shape and form of capsulorhexis IOL stability and the rest will be collected and processed.
In case in which the use of the device will not perform a round and regular capsulorhexis, or instability of the capsule will occur or a un predicted intraocular inflammation will be seen the trail will be stopped immediately
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- senile cataract
Key exclusion criteria (1 listed)
- dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF)
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 |
|---|---|---|
| surgeryAlso: V.R.hexis-1cataract surgery | Device | – |
Primary outcome
capsulorhexis must be round and with regular edge and no tears
Time frame: Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation
As the title of this experiment:"The trying a new device for performing capsulorhexis in cataract surgery".Becuase we are not changing the protocol of Cataract surgery,the outcome measure of this experiment is the efficiency of this device, the safety and the simplicity of the use the device inorder to give a simple and safe solution for capsulorhexis.Therefor the outcome measure will be IOL stability, the shape of capsulorexis and intra ocular post operative inflammation if will occur. The trail is not comparative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
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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.
Joseph Pikkel, Md principal investigator
Ziv Medical Center Sefat Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing surgery in people with Eye Disease and Cataract, run by Ziv Hospital at 1 site in Israel.
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 1 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 3 Aug 2011. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
capsulorhexis must be round and with regular edge and no tears (time frame: Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation). 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 3 Aug 2011.