CataractPhase 4NCT00312299
Posterior Capsule Opacification Study
A Phase 4 study testing Square edge PMMA IOL, Round edge PMMA IOL and Acrysof IOL in people with Cataract, run by Aurolab at 1 site in India.
Trial summary
First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cataract
- What is being tested?
- Square edge PMMA IOL, Round edge PMMA IOL and Acrysof IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2006to Jan 2012
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 65 years
- Bilateral senile cataract
- Pupil should be at least 7mm dilated
- Nuclear sclerosis grade I, II and III
- Patient willing for second eye surgery within 3 months
Who cannot join
- Debilitated old patients
- Cardiac and serious illness
- Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
- Inherent zonular weakness
- Glaucoma patients
- Relative afferent papillary defect (RAPD)
Show all 15Show fewer
- Shallow anterior chamber
- Pseudoexfoliation
- Traumatic cataract
- Uveitis and complicated cataract
- One eyed patients
- Corneal pathology
- Post segment pathology including diabetic retinopathy
- Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC)
- High myopic and hyperopic patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different
Read the detailed description
Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)
The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)
100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.
- Conditions
- Cataract
- Being tested
- Square edge PMMA IOL, Round edge PMMA IOL, Acrysof IOL
- Keywords
- Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square edge PMMA IOLDevice
Also called TrueEdge IOL, S3602SQ
Arm 1 A - Square edge PMMA IOL
Round edge PMMA IOLDevice
Also called S3602
Round edge PMMA IOL
Acrysof IOLDevice
Also called SA60AT
Acrysof IOL
square Edge PMMA IOLDevice
Square edge PMMA intra ocular lens
Square Edge PMMA IOLDevice
Square Edge PMMA IOL lens
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 A - Square edge PMMA IOL | Experimental | 50 patientes will recieve square edge PMMA IOL Receives: Device: Square edge PMMA IOL |
| 1B | Active comparator | In group 1, 50 eyes will receive round edge PMMA IOL Receives: Device: Round edge PMMA IOL |
| 2A | Experimental | In group 2, 50 eyes will receive square edge PMMA IOL Receives: Device: Square Edge PMMA IOL |
| 2B | Active comparator | In group 2, 50 eyes will receive acrysof IOL Receives: Device: Acrysof IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO
Measured: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Secondary outcomes (1)
Visual Acuity
Measured: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2011
- Study completionJan 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haripriya Aravind, MBBS, MS, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312299
- Sponsor's protocol ID
- 2PR1210608
- Status last verified
- Jul 2012
- First submitted
- 7 Apr 2006
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00312299
- Acronym / sponsor ID
- 2PR1210608
- Conditions
- Cataract
- Keywords
- Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Apr 2006 (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.
First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different
Detailed description
Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)
The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)
100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 A - Square edge PMMA IOL | Experimental | Device: Square edge PMMA IOL50 patientes will recieve square edge PMMA IOL |
| 1B | Active comparator | Device: Round edge PMMA IOLIn group 1, 50 eyes will receive round edge PMMA IOL |
| 2A | Experimental | Device: Square Edge PMMA IOLIn group 2, 50 eyes will receive square edge PMMA IOL |
| 2B | Active comparator | Device: Acrysof IOLIn group 2, 50 eyes will receive acrysof IOL |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 to 65 years
- Bilateral senile cataract
- Pupil should be at least 7mm dilated
- Nuclear sclerosis grade I, II and III
- Patient willing for second eye surgery within 3 months
Key exclusion criteria (15 listed)
- Debilitated old patients
- Cardiac and serious illness
- Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
- Inherent zonular weakness
- Glaucoma patients
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 |
|---|---|---|
| Square edge PMMA IOLAlso: TrueEdge IOL, S3602SQArm 1 A - Square edge PMMA IOL | Device | Arm 1 A - Square edge PMMA IOL |
| Round edge PMMA IOLAlso: S3602Round edge PMMA IOL | Device | 1B |
| Acrysof IOLAlso: SA60ATAcrysof IOL | Device | 2B |
| square Edge PMMA IOLSquare edge PMMA intra ocular lens | Device | Arm 1 A - Square edge PMMA IOL |
| Square Edge PMMA IOLSquare Edge PMMA IOL lens | Device | 2A |
Primary outcome
PCO
Time frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
1 secondary outcome
Visual Acuity
Time frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
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 12 Jul 2012.
Related trials for Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
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, MBBS, 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 Square edge PMMA IOL, Round edge PMMA IOL and Acrysof IOL in people with 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 15 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 12 Jul 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. 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?
PCO (time frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year). 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 12 Jul 2012; AzTrials last refreshed its copy on 27 Oct 2026.