Posterior Capsule Opacification After Phacoemulsification and IOL ImplantationNCT01820065
Long-term Evaluation of Single-piece ACrysof IOL Implantation on Development of Posterior Capsule Opacification
An observational study of Posterior Capsule Opacification After Phacoemulsification and IOL Implantation, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Posterior Capsule Opacification After Phacoemulsification and IOL Implantation
- What is being tested?
- Cataract surgery with IOL implantation
- Type of treatment
- Surgery or procedure
- How many people
- 390 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2005to Oct 2011
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing phacoemulsification for age-related uncomplicated phacoemulsification
Who may be able to join
- patients with uncomplicated age-related cataract who were otherwise healthy
Who cannot join
- a history of diabetes mellitus (DM),
- patients with glaucoma,
- high myopia (axial length > 27.0 mm),
- pseudoexfoliation,
- traumatic cataract,
- subluxated cataract,
- previous ocular surgeries, and
- allergy to dilating drops.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term Evaluation of Single-piece Hydrophobic Acrylic Intraocular Lens Implantation on the Development of Posterior Capsule Opacification
Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. A great deal of effort has been made to develop new ways to prevent the formation of PCO. A key factor, widely discussed in literature, is the material and design of the intraocular lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL produces less PCO because of its optic geometry alone or whether the biomaterial contributes to the inhibition of PCO. With the clinical introduction of the single-piece acrylic hydrophobic IOLs with some optic and haptic design differences compared with three-piece acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material and design on PCO prevention. It is well established that the development of PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree of PCO. So far, there have been prospective clinical studies on the clinical results of single and three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the PCO further increases or becomes stable or regresses on a long-term basis has not yet been answered. Since there is paucity of available literature that prospectively evaluates the development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the degree of development of PCO at 5 years after cataract surgery.
- Being tested
- Cataract surgery with IOL implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with IOL implantationProcedure or surgery
Phacoemulsification with implantation of single piece Acrysof IOL
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing phacoemulsification | Patients undergoing phacoemulsification for age-related cataract with implantation of a single-piece Acrysof IOL (SN60AT) Receives: Procedure: Cataract surgery with IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Capsule Opacification
Evaluation of PCO (EPCO) scores in the area of the intraocular lens (IOL) optic and in the central 3mm zone at 5 years after surgery
Measured: 5 years followup
Secondary outcomes (1)
EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic
Measured: 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJun 2005
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule Opacification After Phacoemulsification and IOL ImplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
- Investigators
- Abhay R Vasavada, MS, FRCS, Principal investigator, Iladevi Cataract & IOL Research CentreAbhay R Vasavada, MS,FRCS, Principal investigator, Iladevi Cataract & IOL Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820065
- Sponsor's protocol ID
- 05-003
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Evaluation of Single-piece Hydrophobic Acrylic Intraocular Lens Implantation on the Development of Posterior Capsule Opacification
- ClinicalTrials.gov ID
- NCT01820065
- Acronym / sponsor ID
- 05-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Mar 2013 (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.
Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. A great deal of effort has been made to develop new ways to prevent the formation of PCO. A key factor, widely discussed in literature, is the material and design of the intraocular lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL produces less PCO because of its optic geometry alone or whether the biomaterial contributes to the inhibition of PCO. With the clinical introduction of the single-piece acrylic hydrophobic IOLs with some optic and haptic design differences compared with three-piece acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material and design on PCO prevention. It is well established that the development of PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree of PCO. So far, there have been prospective clinical studies on the clinical results of single and three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the PCO further increases or becomes stable or regresses on a long-term basis has not yet been answered. Since there is paucity of available literature that prospectively evaluates the development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the degree of development of PCO at 5 years after cataract surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing phacoemulsification | – | Procedure: Cataract surgery with IOL implantationPatients undergoing phacoemulsification for age-related cataract with implantation of a single-piece Acrysof IOL (SN60AT) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing phacoemulsification for age-related uncomplicated phacoemulsification
Key inclusion criteria (1 listed)
- patients with uncomplicated age-related cataract who were otherwise healthy
Key exclusion criteria (8 listed)
- a history of diabetes mellitus (DM),
- patients with glaucoma,
- high myopia (axial length > 27.0 mm),
- pseudoexfoliation,
- traumatic cataract,
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 |
|---|---|---|
| Cataract surgery with IOL implantationPhacoemulsification with implantation of single piece Acrysof IOL | Procedure or surgery | Patients undergoing phacoemulsification |
Primary outcome
Posterior Capsule Opacification
Time frame: 5 years followup
Evaluation of PCO (EPCO) scores in the area of the intraocular lens (IOL) optic and in the central 3mm zone at 5 years after surgery
1 secondary outcome
EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic
Time frame: 5 years postoperatively
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 28 Mar 2013.
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
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?
An observational study of Posterior Capsule Opacification After Phacoemulsification and IOL Implantation, 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 1 inclusion and 8 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 28 Mar 2013. 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?
Posterior Capsule Opacification (time frame: 5 years followup). 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 28 Mar 2013.