To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses

Visual Acuity Clinical Trial

Official title:

Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223857
• Other study ID #: 102/13
• Status: Completed
• Start date: April 9, 2013
• Est. completion date: March 23, 2019

Study information

• Verified date: March 2019
• Source: University Clinic Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.

Description:

This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.

Patients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of >1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 23, 2019
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens

• a regular corneal astigmatism < 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)

Exclusion Criteria:

• other previous ocular surgeries

• ocular pathologies

• corneal abnormalities

• endothelial cell count below 2000/mm²

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Procedure:
• Femtosecond-laser-assisted lens exchange
Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange

Locations

Country	Name	City	State
Germany	Department of ophthalmology University clinic Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity at intermediate distance	Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Best corrected visual acuity at far distance	Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Best corrected visual acuity at near distance	Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Uncorrected visual acuity at far distance	Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Uncorrected visual acuity at intermediate distance	Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Uncorrected visual acuity at near distance	Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Secondary	Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions	Binocular contrast sensitivity (CS) was measured under photopic, mesopic (0.167 cd/m²), and mesopic with glare lighting conditions by means of the "Frankfurt-Freiburg Contrast and Acuity Test System" (FF-CATS)	Measured 3 month after lens surgery
Secondary	Defocus curve testing	Defocus curve (monocular and binocular) was tested from -5.0 D to +2.0 D in 0.5 D steps under photopic lighting conditions (ETDRS).	Measured 3 month after lens surgery