Lens SubluxationPhase 3NCT01346566
Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
A Phase 3 study testing Cionni Modified Capsule Tension Ring in people with Lens Subluxation, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lens Subluxation
- What is being tested?
- Cionni Modified Capsule Tension Ring
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2003to Dec 2010
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subluxated Lenses
- Traumatic or Non-traumatic etiology
Who cannot join
- Dislocated Lenses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series
The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.
Read the detailed description
The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.
- Conditions
- Lens Subluxation
- Being tested
- Cionni Modified Capsule Tension Ring
- Keywords
- Cionni Ring, In-the-bag IOL, Subluxated lenses, Intraoperative Performance, Postoperative Outcome
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cionni Modified Capsule Tension RingDevice
Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL Centration
Measured: 4 years follow-up
Secondary outcomes (3)
Complications
Measured: 4 years follow-up
IOP
Measured: 4 years
Posterior Capsule Opacification
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startJan 2003
- Primary completionDec 2010
- Study completionDec 2010
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 Lens SubluxationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Abhay R Vasavada, MS, FRCS, Principal investigator, Iladevi Cataract & IOL Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346566
- Sponsor's protocol ID
- ICIRCcionni
- Status last verified
- May 2011
- First submitted
- 30 Apr 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vasavada AR, Praveen MR, Vasavada VA, Yeh RY, Srivastava S, Koul A, Trivedi RH. Cionni ring and in-the-bag intraocular lens implantation for subluxated lenses: a prospective case series. Am J Ophthalmol. 2012 Jun;153(6):1144-53.e1. doi: 10.1016/j.ajo.2011.11.012. Epub 2012 Feb 7.
PubMed 22317913
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT01346566
- Acronym / sponsor ID
- ICIRCcionni
- Conditions
- Lens Subluxation
- Keywords
- Cionni Ring, In-the-bag IOL, Subluxated lenses, Intraoperative Performance, Postoperative Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 May 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.
The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.
Detailed description
The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subluxated Lenses
- Traumatic or Non-traumatic etiology
Key exclusion criteria (1 listed)
- Dislocated Lenses
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 |
|---|---|---|
| Cionni Modified Capsule Tension RingCionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag | Device | – |
Primary outcome
IOL Centration
Time frame: 4 years follow-up
3 secondary outcomes
Complications
Time frame: 4 years follow-up
IOP
Time frame: 4 years
Posterior Capsule Opacification
Time frame: 4 years
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 19 May 2011.
- Derived from this study: PubMed 22317913Vasavada AR, Praveen MR, Vasavada VA, Yeh RY, Srivastava S, Koul A, Trivedi RH. Cionni ring and in-the-bag intraocular lens implantation for subluxated lenses: a prospective case series. Am J Ophthalmol. 2012 Jun;153(6):1144-53.e1. doi: 10.1016/j.ajo.2011.11.012. Epub 2012 Feb 7.
Related trials for Lens Subluxation
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
Recruiting
Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children
Ectopia Lentis, Lens Subluxation or Dislocation
Recruiting
Sutureless Technique for Repositioning and Scleral Fixation of the Capsular Bag - Intraocular Lens Complex With Permanent Use of Iris Retractors
Lens Subluxation
Active, not recruiting
Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence
Ectopia Lentis
RecruitingObservational study
Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
Ectopia Lentis, Dislocation, Lens
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cionni Modified Capsule Tension Ring in people with Lens Subluxation, run by Iladevi Cataract and IOL Research Center at 1 site in India.
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 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: finished, as of the sponsor's last update on 19 May 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IOL Centration (time frame: 4 years follow-up). 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 NCT01346566, 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 19 May 2011.