Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Vienna
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Change of axial intraocular lens position
Study Overview
Brief Summary
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Investigator will be masked to which axis the IOL will be implanted until a sealed envelope will be opened in the operating theater.
Eligibility Criteria
- Ages
- 45 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- •Need for spherical IOL correction between +0.00 and +32.00 D
- •Pupil dilation of ≥ 7.0 mm
- •Age 45 to 95
Exclusion Criteria
- •Corneal abnormality (Corneal scaring)
- •Preceding ocular surgery or trauma
- •Uncontrolled glaucoma
- •Proliferative diabetic retinopathy
- •Iris neovascularization
- •History of uveitis/iritis
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
- •Pregnancy
- •Lactation
Arms & Interventions
Axis 0
IOL Implantation at the 0 +/- 10 degrees axis
Intervention: Implantation of an intraocular lens (Device)
Axis 45
IOL Implantation at the 45 +/- 10 degrees axis
Intervention: Implantation of an intraocular lens (Device)
Axis 90
IOL Implantation at the 90 +/- 10 degrees axis
Intervention: Implantation of an intraocular lens (Device)
Axis 135
IOL Implantation at the 135 +/- 10 degrees axis
Intervention: Implantation of an intraocular lens (Device)
Outcomes
Primary Outcomes
Change of axial intraocular lens position
Time Frame: 7 months
Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Secondary Outcomes
- Tilt(7 months)
- Anterior chamber depth(7 months)
- Best corrected visual acuity (BCVA)(7 months)
- Decentration(7 months)
Investigators
Rupert Menapace
Ao. Univ. Prof. Dr.
Medical University of Vienna