Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular lens
Eligibility Criteria
Inclusion Criteria:
- diagnosis of bilateral age-related cataract and age between 60 to 85 years
Exclusion Criteria:
- 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
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single-piece IOL Group
Three-piece IOL Group
Arm Description
Age-related cataract patients receive in-the-bag implantation of a single-piece IOL
Age-related cataract patients receive in-the-bag implantation of a three-piece IOL
Outcomes
Primary Outcome Measures
The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Secondary Outcome Measures
The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Full Information
NCT ID
NCT02609997
First Posted
November 14, 2015
Last Updated
November 18, 2015
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02609997
Brief Title
Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
Official Title
Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens Via Scheimpflug Imaging System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-piece IOL Group
Arm Type
Experimental
Arm Description
Age-related cataract patients receive in-the-bag implantation of a single-piece IOL
Arm Title
Three-piece IOL Group
Arm Type
Experimental
Arm Description
Age-related cataract patients receive in-the-bag implantation of a three-piece IOL
Intervention Type
Procedure
Intervention Name(s)
Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation
Intervention Description
The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.
Intervention Type
Procedure
Intervention Name(s)
Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation
Intervention Description
The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
Intervention Type
Drug
Intervention Name(s)
Subconjunctival dexamethasone
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Viscoelastic materials
Intervention Description
viscoelastic materials are used to protect corneal endothelial cells
Intervention Type
Drug
Intervention Name(s)
proparacaine
Intervention Description
0.5% proparacaine (Alcaine, Alcon Laboratories)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Time Frame
3 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of bilateral age-related cataract and age between 60 to 85 years
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weirong Chen, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
7530106
Citation
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.
Results Reference
background
PubMed Identifier
16157803
Citation
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.
Results Reference
background
PubMed Identifier
16539046
Citation
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.
Results Reference
background
PubMed Identifier
17321392
Citation
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.
Results Reference
background
PubMed Identifier
27392024
Citation
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.
Results Reference
derived
Links:
URL
http://www.gzzoc.com/
Description
Description Home page of Zhongshan Ophthalmic Center
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Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
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