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

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT04226196

Collaborator

(none)

Enrollment

Location

Arms

14.1

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Rotation Capsular Tension Ring	Device: Implantation of an intraocular lens	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 27, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Axis 0 IOL Implantation at the 0 +/- 10 degrees axis	Device: 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.
Experimental: Axis 45 IOL Implantation at the 45 +/- 10 degrees axis	Device: 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.
Experimental: Axis 90 IOL Implantation at the 90 +/- 10 degrees axis	Device: 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.
Experimental: Axis 135 IOL Implantation at the 135 +/- 10 degrees axis	Device: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna Allgemeines Krankenhaus	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Ao. Univ. Prof. Dr., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04226196

Other Study ID Numbers:

ConTRol

First Posted:

Jan 13, 2020

Last Update Posted:

Apr 15, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rupert Menapace, Ao. Univ. Prof. Dr., Medical University of Vienna

Intraocular lens rotation

capsular tension ring

postoperative tilt & decentration

Study Results

No Results Posted as of Apr 15, 2020