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

Medical University of Vienna

Status: Unknown

Conditions: Capsular Tension Ring; Intraocular Lens Rotation

Treatments: Device: Implantation of an intraocular lens

Study type: Interventional

Funder types: Other

Identifiers

NCT04226196

ConTRol

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 4 patient groups

Axis 0

Experimental group

Description:

IOL Implantation at the 0 +/- 10 degrees axis

Treatment:

Device: Implantation of an intraocular lens

Axis 45

Experimental group

Description:

IOL Implantation at the 45 +/- 10 degrees axis

Treatment:

Device: Implantation of an intraocular lens

Axis 90

Experimental group

Description:

IOL Implantation at the 90 +/- 10 degrees axis

Treatment:

Device: Implantation of an intraocular lens

Axis 135

Experimental group

Description:

IOL Implantation at the 135 +/- 10 degrees axis

Treatment:

Device: Implantation of an intraocular lens