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

Capsular Tension Ring Clinical Trial

— ConTRol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226196
• Other study ID #: ConTRol
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: April 2021

Study information

• Verified date: April 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsular Tension Ring
• Intraocular Lens Rotation

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna Allgemeines Krankenhaus	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of axial intraocular lens position	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°)	7 months
Secondary	Decentration	Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in millimeter"	7 months
Secondary	Tilt	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"	7 months
Secondary	Anterior chamber depth	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	7 months
Secondary	Best corrected visual acuity (BCVA)	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)	7 months