Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study

NCT ID: NCT04226196

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2021-04-30

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.

Conditions

Intraocular Lens Rotation; Capsular Tension Ring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Axis 0

IOL Implantation at the 0 +/- 10 degrees axis

Group Type: EXPERIMENTAL

Implantation of an intraocular lens

Intervention Type: DEVICE

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Axis 45

IOL Implantation at the 45 +/- 10 degrees axis

Group Type: EXPERIMENTAL

Implantation of an intraocular lens

Intervention Type: DEVICE

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Axis 90

IOL Implantation at the 90 +/- 10 degrees axis

Group Type: EXPERIMENTAL

Implantation of an intraocular lens

Intervention Type: DEVICE

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Axis 135

IOL Implantation at the 135 +/- 10 degrees axis

Group Type: EXPERIMENTAL

Implantation of an intraocular lens

Intervention Type: DEVICE

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Interventions

Implantation of an intraocular lens

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Menapace

Ao. Univ. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna Allgemeines Krankenhaus

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Rupert Menapace, Prof.

Role: primary

rupert.menapace@meduniwien.ac.at

014040066300

Other Identifiers

ConTRol

Identifier Type: -

Identifier Source: org_study_id