- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609997
Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation
- Drug: Subconjunctival dexamethasone
- Device: Viscoelastic materials
- Drug: proparacaine
- Procedure: Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhognshan Ophthalmic Center, Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-piece IOL Group
Age-related cataract patients receive in-the-bag implantation of a single-piece IOL
|
The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.
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 are used to protect corneal endothelial cells
0.5% proparacaine (Alcaine, Alcon Laboratories)
|
Experimental: Three-piece IOL Group
Age-related cataract patients receive in-the-bag implantation of a three-piece IOL
|
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 are used to protect corneal endothelial cells
0.5% proparacaine (Alcaine, Alcon Laboratories)
The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)
Time Frame: 3 months after the surgery
|
3 months after the surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Lens Diseases
- Cataract
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Dexamethasone
- Proxymetacaine
Other Study ID Numbers
- CCPMOH2010-China9
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