CataractNCT02609997
Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
A study testing Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation and Subconjunctival dexamethasone in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation and Subconjunctival dexamethasone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2012
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bilateral age-related cataract and age between 60 to 85 years
Who cannot join
- vision-impairing diseases other than cataract, severe refractive error (Preoperative spherical equivalent of either eye >-6.00D or +5.00D)
- history of ocular trauma, past refractive surgery or other ophthalmic surgery, capsular or zonular disorders that might affect the post-operative centration of IOLs
- surgical complications including severe hyphema, iris injury, repeated IOL implantation
- unable to achieve in-the-bag implantation of IOL, corneal sutures during surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens Via Scheimpflug Imaging System
Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.
As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.
Read the detailed description
Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.
As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.
Most previous studies measure the IOL position based on Purkinje reflections. The measurement is time-consuming and patients are reluctant to cooperate during image acquisition. Purkinje measurement does not detect anterior chamber depth (ACD) and as such cannot reveal the IOL position along the axis. Clinical Scheimpflug systems based on rotating Scheimpflug imaging, on the other hand, is able to acquire sufficient 3-dimensioinal data points within a reasonably short period, usually seconds. It was shown that these systems are one of the best methods to estimate IOL position. To better compare the intracapsular stability between single-piece and 3-piece IOLs, the investigators measured IOL positions with rotating Scheimpflug imaging systems and tested the visual quality of patients implanted with these IOLs.
- Conditions
- Cataract
- Being tested
- Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation, Subconjunctival dexamethasone, Viscoelastic materials, proparacaine
- Keywords
- Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantationProcedure or surgery
The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.
Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantationProcedure or surgery
The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
Subconjunctival dexamethasoneDrug
All patients received subconjunctival dexamethasone (2 mg) during surgery. Topical anesthesia, consisting of a single drop of 0.5% proparacaine (Alcaine, Alcon Laboratories), was administered three times at intervals of 5 minutes prior to surgery
Viscoelastic materialsDevice
viscoelastic materials are used to protect corneal endothelial cells
proparacaineDrug
0.5% proparacaine (Alcaine, Alcon Laboratories)
| Study group | Role | What they receive |
|---|---|---|
| Single-piece IOL Group | Experimental | Age-related cataract patients receive in-the-bag implantation of a single-piece IOL Receives: Procedure: Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation; Drug: Subconjunctival dexamethasone; Device: Viscoelastic materials; Drug: proparacaine |
| Three-piece IOL Group | Experimental | Age-related cataract patients receive in-the-bag implantation of a three-piece IOL Receives: Procedure: Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation; Drug: Subconjunctival dexamethasone; Device: Viscoelastic materials; Drug: proparacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Measured: 3 months after the surgery
Secondary outcomes (1)
The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609997
- Sponsor's protocol ID
- CCPMOH2010-China9
- Status last verified
- Nov 2015
- First submitted
- 14 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Korynta J, Bok J, Cendelin J. Changes in refraction induced by change in intraocular lens position. J Refract Corneal Surg. 1994 Sep-Oct;10(5):556-64.
PubMed 7530106Wang L, Koch DD. Effect of decentration of wavefront-corrected intraocular lenses on the higher-order aberrations of the eye. Arch Ophthalmol. 2005 Sep;123(9):1226-30. doi: 10.1001/archopht.123.9.1226.
PubMed 16157803Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006 Mar;23(3):509-20. doi: 10.1364/josaa.23.000509.
PubMed 16539046de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
PubMed 17321392Zhong X, Long E, Chen W, Xiang W, Liu Z, Chen H, Chen J, Lin Z, Lin H, Chen W. Comparisons of the in-the-bag stabilities of single-piece and three-piece intraocular lenses for age-related cataract patients: a randomized controlled trial. BMC Ophthalmol. 2016 Jul 8;16:100. doi: 10.1186/s12886-016-0283-4.
PubMed 27392024
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens Via Scheimpflug Imaging System
- ClinicalTrials.gov ID
- NCT02609997
- Acronym / sponsor ID
- CCPMOH2010-China9
- Conditions
- Cataract
- Keywords
- Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Nov 2015 (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.
Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.
As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.
Detailed description
Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have enabled the transition of cataract surgery from blindness relief to refractive correction. An ideal IOL is the critical component to achieve the refractive target of cataract surgery. Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all been suggested as the critical factors of an ideal IOL and widely investigated. Recently, stability of IOL position has also been suggested as one of those critical factors due to its close correlation with postoperative visual function. Data suggests that IOL forward movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional surgery that put both surgeons and patients in pain.
As the supporting element of an IOL, the haptics are crucial to keep the IOL in place. Various haptic designs are being compared in terms of position stability of IOLs. Haptic designs of single-piece versus 3-piece are often compared because they are currently the most commonly used types. Single-piece IOLs have soft and broader haptics which are made of the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies comparing these haptic designs have yielded controversial results regarding their position stability in the capsular bag, which is the most recommended site for IOL fixation in an uneventful cataract surgery.
Most previous studies measure the IOL position based on Purkinje reflections. The measurement is time-consuming and patients are reluctant to cooperate during image acquisition. Purkinje measurement does not detect anterior chamber depth (ACD) and as such cannot reveal the IOL position along the axis. Clinical Scheimpflug systems based on rotating Scheimpflug imaging, on the other hand, is able to acquire sufficient 3-dimensioinal data points within a reasonably short period, usually seconds. It was shown that these systems are one of the best methods to estimate IOL position. To better compare the intracapsular stability between single-piece and 3-piece IOLs, the investigators measured IOL positions with rotating Scheimpflug imaging systems and tested the visual quality of patients implanted with these IOLs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-piece IOL Group | Experimental | Procedure: Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation, Drug: Subconjunctival dexamethasone, Device: Viscoelastic materials, Drug: proparacaineAge-related cataract patients receive in-the-bag implantation of a single-piece IOL |
| Three-piece IOL Group | Experimental | Procedure: Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation, Drug: Subconjunctival dexamethasone, Device: Viscoelastic materials, Drug: proparacaineAge-related cataract patients receive in-the-bag implantation of a three-piece IOL |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of bilateral age-related cataract and age between 60 to 85 years
Key exclusion criteria (4 listed)
- vision-impairing diseases other than cataract, severe refractive error (Preoperative spherical equivalent of either eye >-6.00D or +5.00D)
- history of ocular trauma, past refractive surgery or other ophthalmic surgery, capsular or zonular disorders that might affect the post-operative centration of IOLs
- surgical complications including severe hyphema, iris injury, repeated IOL implantation
- unable to achieve in-the-bag implantation of IOL, corneal sutures during surgery
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 |
|---|---|---|
| Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantationThe phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification. | Procedure or surgery | Single-piece IOL Group |
| Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantationThe phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification. | Procedure or surgery | Three-piece IOL Group |
| Subconjunctival dexamethasoneAll patients received subconjunctival dexamethasone (2 mg) during surgery. Topical anesthesia, consisting of a single drop of 0.5% proparacaine (Alcaine, Alcon Laboratories), was administered three times at intervals of 5 minutes prior to surgery | Drug | Single-piece IOL Group, Three-piece IOL Group |
| Viscoelastic materialsviscoelastic materials are used to protect corneal endothelial cells | Device | Single-piece IOL Group, Three-piece IOL Group |
| proparacaine0.5% proparacaine (Alcaine, Alcon Laboratories) | Drug | Single-piece IOL Group, Three-piece IOL Group |
Primary outcome
The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Time frame: 3 months after the surgery
1 secondary outcome
The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Time frame: 3 months after the surgery
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 20 Nov 2015.
- Background: PubMed 7530106Korynta J, Bok J, Cendelin J. Changes in refraction induced by change in intraocular lens position. J Refract Corneal Surg. 1994 Sep-Oct;10(5):556-64.
- Background: PubMed 16157803Wang L, Koch DD. Effect of decentration of wavefront-corrected intraocular lenses on the higher-order aberrations of the eye. Arch Ophthalmol. 2005 Sep;123(9):1226-30. doi: 10.1001/archopht.123.9.1226.
- Background: PubMed 16539046Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006 Mar;23(3):509-20. doi: 10.1364/josaa.23.000509.
- Background: PubMed 17321392de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
- Derived from this study: PubMed 27392024Zhong X, Long E, Chen W, Xiang W, Liu Z, Chen H, Chen J, Lin Z, Lin H, Chen W. Comparisons of the in-the-bag stabilities of single-piece and three-piece intraocular lenses for age-related cataract patients: a randomized controlled trial. BMC Ophthalmol. 2016 Jul 8;16:100. doi: 10.1186/s12886-016-0283-4.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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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.
Haotian Lin, M.D., Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation and Subconjunctival dexamethasone in people with Cataract, run by Sun Yat-sen University at 1 site in China.
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 4 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 20 Nov 2015. 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 China. 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 grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs) (time frame: 3 months after the surgery). 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 NCT02609997, which also lists 5 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 20 Nov 2015.