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Completed

NCT Number: NCT02609997

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

Viscoelastic materials

Device

viscoelastic materials are used to protect corneal endothelial cells

Proparacaine

Drug

0.5% proparacaine (Alcaine, Alcon Laboratories)

Primary outcomes

  1. 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 outcomes

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

    Time frame: 3 months after the surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Comparison of In-the-bag Stability Between Single-piece and Three-piece Intraocular Lens Via Scheimpflug Imaging System

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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