Posterior Capsule OpacificationNCT00855491
Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL
A study testing Phaco in people with Posterior Capsule Opacification, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
The purpose of this study what to evaluate if axial myopia might influence the development of PCO. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- Phaco
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2003to Nov 2008
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- local residency and presence of a cataract in an otherwise normal eye.
- Patients older than 50 years
- a dilated pupil after mydriasis
- Patients with retinochoroidal atrophy, retinal laser prophylaxis,
- hypertension
Who cannot join
- nondilating pupil after maximal dilation;
- pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
- previous intraocular surgery;
- previous surgery for glaucoma;
- uveitis
- diabetes mellitus
- Patients who did not give consent preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation
The purpose of this study what to evaluate if axial myopia might influence the development of PCO.
Read the detailed description
We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.
- Conditions
- Posterior Capsule Opacification
- Being tested
- Phaco
- Keywords
- PCO, POCO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoProcedure or surgery
Also called emmetropic eyes, normal axial length
AcrySof Single-Piece IOL
| Study group | Role | What they receive |
|---|---|---|
| 1. MYOPIA | Experimental | axial length > 26.00 mm Receives: Procedure: Phaco |
| 2. Emmetropia | Active comparator | emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm Receives: Procedure: Phaco |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage area of PCO with posterior capsule opacity (POCO) software
Measured: 4 years
Secondary outcomes (1)
the presence of PCO within the central 3-mm zone were noted
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 posted4 Mar 2009 (estimated)
- Study startJul 2003
- Primary completionSep 2004
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- ALPESH SHAH, MS, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855491
- Sponsor's protocol ID
- 03-009
- Status last verified
- Mar 2009
- First submitted
- 3 Mar 2009
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation
- ClinicalTrials.gov ID
- NCT00855491
- Acronym / sponsor ID
- 03-009
- Conditions
- Posterior Capsule Opacification
- Keywords
- PCO, POCO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Mar 2009 (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 what to evaluate if axial myopia might influence the development of PCO.
Detailed description
We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. MYOPIA | Experimental | Procedure: Phacoaxial length > 26.00 mm |
| 2. Emmetropia | Active comparator | Procedure: Phacoemmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- local residency and presence of a cataract in an otherwise normal eye.
- Patients older than 50 years
- a dilated pupil after mydriasis
- Patients with retinochoroidal atrophy, retinal laser prophylaxis,
- hypertension
Key exclusion criteria (7 listed)
- nondilating pupil after maximal dilation;
- pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
- previous intraocular surgery;
- previous surgery for glaucoma;
- uveitis
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 |
|---|---|---|
| PhacoAlso: emmetropic eyes, normal axial lengthAcrySof Single-Piece IOL | Procedure or surgery | 1. MYOPIA, 2. Emmetropia |
Primary outcome
the percentage area of PCO with posterior capsule opacity (POCO) software
Time frame: 4 years
1 secondary outcome
the presence of PCO within the central 3-mm zone were noted
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 4 Mar 2009.
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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.
ALPESH SHAH, MS principal investigator
Iladevi Cataract and IOL Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaco in people with Posterior Capsule Opacification, 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 5 inclusion and 7 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 4 Mar 2009. 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.
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 area of PCO with posterior capsule opacity (POCO) software (time frame: 4 years). 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 4 Mar 2009.