Cataract Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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