Posterior Capsule OpacificationPhase 4NCT01125345
Posterior Capsule Opacification (PCO) With Single Piece Hydrophobic Versus Hydrophillic Intraocular Lens (IOL)
A Phase 4 study testing Phacoemulsification in people with Posterior Capsule Opacification, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
The purpose of the study was to compare the postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2006to Dec 2009
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral senile surgery
- age ranged from 53 to 78 years
- pupil mydriasis > 7 mm
- No history of previous ocular surgery
- gave consent for followup examination
Who cannot join
- coexisting ocular morbidities
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Controlled Clinical Trial to Evaluate the Posterior Capsule Opacification in Contralateral Eyes Implanted With Single Piece Hydrophobic AcrySof IOL and Single Piece Hydrophilic Acrylic IOLs
The purpose of the study was to compare the postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.
Read the detailed description
Amongst several surgical techniques and IOL technology that influence the opacification of the posterior capsule, the role of IOL material and optic design remain crucial in determining its development. The single-piece Acrylic IOLs with a hydrophobic surface have been widely used in practice. The single-piece Acrylic IOLs with a hydrophilic surface became commercially available more recently. Although there is a study that compared the single piece hydrophobic and the single piece hydrophilic IOL, it was conducted on the older generation of the hydrophilic IOL. Moreover, experimental and clinical study has been performed to evaluate the posterior capsule opacification between the Hydrophilic acrylic IOL with a sharp optic edge design excluding the optic-haptic junction, versus the newer generation hydrophilic IOL design which has an improved 360-degree sharp edge, with results favouring the latter design. There is little data that compares the single-piece Acrylic IOLs with a hydrophobic surface to the newer generation single-piece Acrylic IOLs with a hydrophilic surface. Because the IOL characteristics play a crucial role to prevent posterior capsule opacification (PCO), it is of clinical importance, as well as investigational interest to assess the PCO following implantation of these IOLs. We conducted a prospective, randomised, intra-individual study to compare the 3 year postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.
- Conditions
- Posterior Capsule Opacification
- Being tested
- Phacoemulsification
- Keywords
- hydrophobic acrylic, PCO, posterior capsule opacification, hydrophilic acrylic IO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Hydrophobic IOL | Experimental | The single piece Acrysof hydrophobic IOL model- SN60WF Receives: Procedure: Phacoemulsification |
| Hydrophilic IOL | Active comparator | Rayner Intraocular Lenses Ltd., England, Model C-flex 570C Receives: Procedure: Phacoemulsification |
| Hydrophillic IOL | Active comparator | Bausch and Lomb ltd, model Akreos Adapt Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
posterior capsule evaluation
Measured: 3 years
Secondary outcomes (1)
ND-Yag capsulotomy rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Abhay Vasavada, MD, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125345
- Sponsor's protocol ID
- 06-009
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansson B. Clinical consequences of acrylic intraocular lens material and design: Nd:YAG-laser capsulotomy rates in 3 x 300 eyes 5 years after phacoemulsification. Br J Ophthalmol. 2010 Apr;94(4):450-5. doi: 10.1136/bjo.2009.166181. Epub 2009 Oct 14.
PubMed 19828518Lombardo M, Carbone G, Lombardo G, De Santo MP, Barberi R. Analysis of intraocular lens surface adhesiveness by atomic force microscopy. J Cataract Refract Surg. 2009 Jul;35(7):1266-72. doi: 10.1016/j.jcrs.2009.02.029.
PubMed 19545819Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Two-year follow-up of posterior capsule opacification after implantation of a hydrophilic or hydrophobic acrylic intraocular lens. Acta Ophthalmol. 2008 Aug;86(5):533-6. doi: 10.1111/j.1600-0420.2007.01094.x. Epub 2007 Dec 11.
PubMed 18081899Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow-up. J Cataract Refract Surg. 2006 Oct;32(10):1627-31. doi: 10.1016/j.jcrs.2006.05.011.
PubMed 17010858Heatley CJ, Spalton DJ, Kumar A, Jose R, Boyce J, Bender LE. Comparison of posterior capsule opacification rates between hydrophilic and hydrophobic single-piece acrylic intraocular lenses. J Cataract Refract Surg. 2005 Apr;31(4):718-24. doi: 10.1016/j.jcrs.2004.08.060.
PubMed 15899448Werner L, Mamalis N, Pandey SK, Izak AM, Nilson CD, Davis BL, Weight C, Apple DJ. Posterior capsule opacification in rabbit eyes implanted with hydrophilic acrylic intraocular lenses with enhanced square edge. J Cataract Refract Surg. 2004 Nov;30(11):2403-9. doi: 10.1016/j.jcrs.2004.02.085.
PubMed 15519096Nishi Y, Rabsilber TM, Limberger IJ, Reuland AJ, Auffarth GU. Influence of 360-degree enhanced optic edge design of a hydrophilic acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2007 Feb;33(2):227-31. doi: 10.1016/j.jcrs.2006.10.020.
PubMed 17276262
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Clinical Trial to Evaluate the Posterior Capsule Opacification in Contralateral Eyes Implanted With Single Piece Hydrophobic AcrySof IOL and Single Piece Hydrophilic Acrylic IOLs
- ClinicalTrials.gov ID
- NCT01125345
- Acronym / sponsor ID
- 06-009
- Conditions
- Posterior Capsule Opacification
- Keywords
- hydrophobic acrylic, PCO, posterior capsule opacification, hydrophilic acrylic IO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 May 2010 (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 the study was to compare the postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.
Detailed description
Amongst several surgical techniques and IOL technology that influence the opacification of the posterior capsule, the role of IOL material and optic design remain crucial in determining its development. The single-piece Acrylic IOLs with a hydrophobic surface have been widely used in practice. The single-piece Acrylic IOLs with a hydrophilic surface became commercially available more recently. Although there is a study that compared the single piece hydrophobic and the single piece hydrophilic IOL, it was conducted on the older generation of the hydrophilic IOL. Moreover, experimental and clinical study has been performed to evaluate the posterior capsule opacification between the Hydrophilic acrylic IOL with a sharp optic edge design excluding the optic-haptic junction, versus the newer generation hydrophilic IOL design which has an improved 360-degree sharp edge, with results favouring the latter design. There is little data that compares the single-piece Acrylic IOLs with a hydrophobic surface to the newer generation single-piece Acrylic IOLs with a hydrophilic surface. Because the IOL characteristics play a crucial role to prevent posterior capsule opacification (PCO), it is of clinical importance, as well as investigational interest to assess the PCO following implantation of these IOLs. We conducted a prospective, randomised, intra-individual study to compare the 3 year postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrophobic IOL | Experimental | Procedure: PhacoemulsificationThe single piece Acrysof hydrophobic IOL model- SN60WF |
| Hydrophilic IOL | Active comparator | Procedure: PhacoemulsificationRayner Intraocular Lenses Ltd., England, Model C-flex 570C |
| Hydrophillic IOL | Active comparator | Procedure: PhacoemulsificationBausch and Lomb ltd, model Akreos Adapt |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- bilateral senile surgery
- age ranged from 53 to 78 years
- pupil mydriasis > 7 mm
- No history of previous ocular surgery
- gave consent for followup examination
Key exclusion criteria (2 listed)
- coexisting ocular morbidities
- diabetes mellitus
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 |
|---|---|---|
| PhacoemulsificationPhacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery | Procedure or surgery | Hydrophilic IOL, Hydrophillic IOL, Hydrophobic IOL |
Primary outcome
posterior capsule evaluation
Time frame: 3 years
1 secondary outcome
ND-Yag capsulotomy rate
Time frame: 3 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 Jun 2010.
- Background: PubMed 19828518Johansson B. Clinical consequences of acrylic intraocular lens material and design: Nd:YAG-laser capsulotomy rates in 3 x 300 eyes 5 years after phacoemulsification. Br J Ophthalmol. 2010 Apr;94(4):450-5. doi: 10.1136/bjo.2009.166181. Epub 2009 Oct 14.
- Background: PubMed 19545819Lombardo M, Carbone G, Lombardo G, De Santo MP, Barberi R. Analysis of intraocular lens surface adhesiveness by atomic force microscopy. J Cataract Refract Surg. 2009 Jul;35(7):1266-72. doi: 10.1016/j.jcrs.2009.02.029.
- Background: PubMed 18081899Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Two-year follow-up of posterior capsule opacification after implantation of a hydrophilic or hydrophobic acrylic intraocular lens. Acta Ophthalmol. 2008 Aug;86(5):533-6. doi: 10.1111/j.1600-0420.2007.01094.x. Epub 2007 Dec 11.
- Background: PubMed 17010858Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow-up. J Cataract Refract Surg. 2006 Oct;32(10):1627-31. doi: 10.1016/j.jcrs.2006.05.011.
- Background: PubMed 15899448Heatley CJ, Spalton DJ, Kumar A, Jose R, Boyce J, Bender LE. Comparison of posterior capsule opacification rates between hydrophilic and hydrophobic single-piece acrylic intraocular lenses. J Cataract Refract Surg. 2005 Apr;31(4):718-24. doi: 10.1016/j.jcrs.2004.08.060.
- Background: PubMed 15519096Werner L, Mamalis N, Pandey SK, Izak AM, Nilson CD, Davis BL, Weight C, Apple DJ. Posterior capsule opacification in rabbit eyes implanted with hydrophilic acrylic intraocular lenses with enhanced square edge. J Cataract Refract Surg. 2004 Nov;30(11):2403-9. doi: 10.1016/j.jcrs.2004.02.085.
- Background: PubMed 17276262Nishi Y, Rabsilber TM, Limberger IJ, Reuland AJ, Auffarth GU. Influence of 360-degree enhanced optic edge design of a hydrophilic acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2007 Feb;33(2):227-31. doi: 10.1016/j.jcrs.2006.10.020.
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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.
Abhay Vasavada, MD 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 Phase 4 study testing Phacoemulsification 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 2 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 Jun 2010. 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?
posterior capsule evaluation (time frame: 3 years). 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 NCT01125345, which also lists 7 linked publications.
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 Jun 2010.