Retinitis PigmentosaPhase 4ACONCT00717080
The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction
A Phase 4 study testing IOL surgery in people with Retinitis Pigmentosa and Cataract, run by Aurolab at 1 site in India.
Trial summary
This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Retinitis Pigmentosa, Cataract
- What is being tested?
- IOL surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2008to Jun 2010
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 to 65 years
- Typical retinitis pigmentosa
- Reside within a radius of 100kms from Madurai
- Patients willing to come for follow up
- Patients with nuclear sclerosis grade 2 or 3 or cortical cataract or pscc
Who cannot join
- Diabetic patients
- Traumatic cataract
- Uveitis
- Glaucoma
- Pseudoexfoliation
- Myotonic dystrophy
Show all 10Show fewer
- Corneal pathology
- Pupil size <6mm
- Intra op complications like zonular dialysis,pc rupture
- Rhexis not covering iol optic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa
Read the detailed description
Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication following cataract surgery. The rate of which is higher in RP patients due to the weak zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of contraction.
Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the other 20 would not receive CTR. The percentage of anterior capsular contraction would be evaluated using EPCO software.
- Conditions
- Retinitis Pigmentosa, Cataract
- Being tested
- IOL surgery
- Keywords
- Retinitis Pigmentosa, Cataract
- Medical subject headings
- Retinitis Pigmentosa, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL surgeryProcedure or surgery
Also called AURORING
IOL surgery using capsular tension ring (AURORING)
IOL surgeryProcedure or surgery
Also called Phacoemulsification
IOL surgery without CTR
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | IOL surgery with Capsular Tension Ring Receives: Procedure: IOL surgery |
| Arm 2 | Placebo comparator | IOL surgery without Capsular Tension Ring Receives: Procedure: IOL surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of anterior capsular contraction
Measured: 1 day, 30 days,90 days,180 days,270days
Secondary outcomes (1)
Visual acuity
Measured: 1 day, 30 days,90 days,180 days,270days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haripriya Aravind, MS, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717080
- Sponsor's protocol ID
- 2PR1210826
- Acronym
- ACO
- Status last verified
- Oct 2009
- First submitted
- 15 Jul 2008
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
- ClinicalTrials.gov ID
- NCT00717080
- Acronym / sponsor ID
- ACO / 2PR1210826
- Conditions
- Retinitis Pigmentosa, Cataract
- Keywords
- Retinitis Pigmentosa, Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jul 2008 (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 is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa
Detailed description
Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication following cataract surgery. The rate of which is higher in RP patients due to the weak zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of contraction.
Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the other 20 would not receive CTR. The percentage of anterior capsular contraction would be evaluated using EPCO software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: IOL surgeryIOL surgery with Capsular Tension Ring |
| Arm 2 | Placebo comparator | Procedure: IOL surgeryIOL surgery without Capsular Tension Ring |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 35 to 65 years
- Typical retinitis pigmentosa
- Reside within a radius of 100kms from Madurai
- Patients willing to come for follow up
- Patients with nuclear sclerosis grade 2 or 3 or cortical cataract or pscc
Key exclusion criteria (10 listed)
- Diabetic patients
- Traumatic cataract
- Uveitis
- Glaucoma
- Pseudoexfoliation
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 |
|---|---|---|
| IOL surgeryAlso: AURORINGIOL surgery using capsular tension ring (AURORING) | Procedure or surgery | Arm 1 |
| IOL surgeryAlso: PhacoemulsificationIOL surgery without CTR | Procedure or surgery | Arm 2 |
Primary outcome
The percentage of anterior capsular contraction
Time frame: 1 day, 30 days,90 days,180 days,270days
1 secondary outcome
Visual acuity
Time frame: 1 day, 30 days,90 days,180 days,270days
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 25 Jan 2012.
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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.
Haripriya Aravind, MS principal investigator
Aravind Eye Hospital, Madurai
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 IOL surgery in people with Retinitis Pigmentosa and Cataract, run by Aurolab 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 5 inclusion and 10 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 25 Jan 2012. 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. 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?
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?
The percentage of anterior capsular contraction (time frame: 1 day, 30 days,90 days,180 days,270days). 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 25 Jan 2012.