Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
NCT ID: NCT02609997
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2012-09-30
2012-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Single-piece IOL Group
Age-related cataract patients receive in-the-bag implantation of a single-piece IOL
Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.
Subconjunctival dexamethasone
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 materials
viscoelastic materials are used to protect corneal endothelial cells
proparacaine
0.5% proparacaine (Alcaine, Alcon Laboratories)
Three-piece IOL Group
Age-related cataract patients receive in-the-bag implantation of a three-piece IOL
Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
Subconjunctival dexamethasone
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 materials
viscoelastic materials are used to protect corneal endothelial cells
proparacaine
0.5% proparacaine (Alcaine, Alcon Laboratories)
Interventions
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Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation
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) implantation
The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
Subconjunctival dexamethasone
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 materials
viscoelastic materials are used to protect corneal endothelial cells
proparacaine
0.5% proparacaine (Alcaine, Alcon Laboratories)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
60 Years
85 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Principal Investigators
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Haotian Lin, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D.
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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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.
Wang 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.
Rosales 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.
de 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.
Zhong 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.
Related Links
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Description Home page of Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2010-China9
Identifier Type: -
Identifier Source: org_study_id