Capsular Tension Ring, Intraocular Lens Rotation
Conditions
Keywords
Intraocular lens rotation, capsular tension ring, postoperative tilt & decentration
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.
Interventions
Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.
Sponsors
Medical University of Vienna
Study design
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
Sex/Gender
ALL
Age
45 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of axial intraocular lens position | 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
| Measure | Time frame | Description |
|---|---|---|
| Decentration | 7 months | Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as Decentration in millimeter |
| Tilt | 7 months | Tilt of the intraocular lens will be measured with the Casia 2 OCT. Tilt will be described as Tilt in degrees at a certain axis |
| Anterior chamber depth | 7 months | The anterior chamber depth (Axial position of the IOL) of the intraocular lens will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in millimeter |
| Best corrected visual acuity (BCVA) | 7 months | BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar) |
Countries
Austria
Outcome results
None listed