Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens

NCT02609997 | Completed DMC

• 1 other identifier: CCPMOH2010-China9
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Intraocular lens

Outcome Measures

Primary Outcomes (1)

• The grade of in-the-bag stability between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)

  3 months after the surgery

Secondary Outcomes (1)

• The visual acuity between single-piece intraocular lenses (IOLs) and three-piece intraocular lenses(IOLs)

  3 months after the surgery

Study Arms (2)

Single-piece IOL Group

EXPERIMENTAL

Age-related cataract patients receive in-the-bag implantation of a single-piece IOL

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

Procedure: Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation; Drug: Subconjunctival dexamethasone; Device: Viscoelastic materials; Drug: proparacaine

Interventions

Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation PROCEDURE

The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.

Single-piece IOL Group

Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation PROCEDURE

The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.

Three-piece IOL Group

Subconjunctival dexamethasone DRUG

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

Single-piece IOL Group; Three-piece IOL Group

Viscoelastic materials DEVICE

viscoelastic materials are used to protect corneal endothelial cells

Single-piece IOL Group; Three-piece IOL Group

proparacaine DRUG

0.5% proparacaine (Alcaine, Alcon Laboratories)

Single-piece IOL Group; Three-piece IOL Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of bilateral age-related cataract and age between 60 to 85 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 7530106 BACKGROUND

• 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.

  PMID: 16157803 BACKGROUND

• 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.

  PMID: 16539046 BACKGROUND

• 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.

  PMID: 17321392 BACKGROUND

• 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.

  PMID: 27392024 DERIVED

Related Links

• Description Home page of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Interventions

Drug Implants; proxymetacaine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Haotian Lin, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yizhi Liu, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

• Weirong Chen, M.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: November 14, 2015
• First Posted: November 20, 2015
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

CN (1)