Combined EDOF / Trifocal

Cataract Clinical Trial

Official title:

Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462067
• Other study ID #: GPAS-LARALISA-2018-01
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: July 2022
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.

Description:

An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery. In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo & Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire. Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions
• Age 18 and older
• Uncomplicated implantation of study IOLs
• No visual acuity limiting pathologies
• Clear intraocular media
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Written informed consent for participation in the study and data protection

Exclusion Criteria:

• Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders
• Postoperative CDVA >0.2 log MAR
• Visual field loss which has impact on visual acuity
• Use of systemic or ocular medication that might affect vision
• Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
• Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus
• Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
• Patient participates in other clinical trial (former participation is no exclusion criterion)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AT LARA IOL
EDOF IOL for treatment of cataract
• AT LISA Tri IOL
Trifocal IOL for treatment of cataract

Locations

Country	Name	City	State
Denmark	Hellerup Øjenklinik	Hellerup
Germany	Goethe University	Frankfurt
Germany	Augentagesklinik Rheine	Rheine
Ireland	Cathedral Eye Clinic	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Countries where clinical trial is conducted

Denmark,  Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA)	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.; Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.; Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	Pre-op, 2-4 Months, & 5-8 Months
Secondary	Postoperative uncorrected monocular and binocular distance visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.; Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.; Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Secondary	Postoperative uncorrected and distance-corrected binocular near visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.; Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.; Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Secondary	Postoperative uncorrected and distance-corrected binocular intermediate visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.; Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.; Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Secondary	Reading speed and acuity, and preferred reading distance (Salzburg reading desk)	Sites at which the Salzburg Reading Desk is available will examine reading speed and acuity at 40 cm and 66 cm at the two postoperative visits. The following parameters will be documented: words per minute (WPM), characters per minute (CPM), words missed (reading speed recalculated when missed words are selected), LogMAR reading acuity, average reading distance, average reading time.	2-4 Months, & 5-8 Months
Secondary	Postoperative use of spectacles (near, intermediate, distance)	The surgeon asks: "How often do you need glasses for near/intermediate/distance vision?". The answers are classified into 0%, 25%, 50%, 75% and 100% of the total time.	2-4 Months, & 5-8 Months
Secondary	Photic phenomena	The McAlinden Quality of Vision (QoV) questionnaire will be used to assess the size and intensity of halo and glare	2-4 Months, & 5-8 Months
Secondary	Defocus curve	Best-corrected distance defocus curve testing from +1.0 D to -4.0 D shall be performed. The image shall be defocused in -0.5 D increments with spherical minus lenses and a visual acuity measurement is obtained at each defocus increment.	2-4 Months, & 5-8 Months
Secondary	Patient satisfaction	The McAlinden Quality of Vision (QoV) questionnaire will be used to assess patient satisfaction. Patients are asked two closed answered questions, with Yes or No being the answer. 'Would you decide to have multifocal IOLs again?' and ' Would you recommend the same lens to your relatives and friends?'	2-4 Months, & 5-8 Months
Secondary	Surgeon's assessment	The surgeon completes a short questionnaire on the handling and performance of the lens. The ease of implantation, achievement of the target refraction, satisfaction with the patient's vision and general satisfaction are recorded.	2-4 Months, & 5-8 Months
Secondary	Optimization of IOL-constants	For this purpose, the corneal radii, the axial length, the measured anterior chamber depth and the implanted IOL power are recorded during biometry to determine the correct IOL power. Postoperatively, the subjective refraction achieved is documented as spherical equivalent and forwarded to Prof. Dr. Achim Langenbucher, Medical Faculty of Saarland University, Experimental Ophthalmology, for evaluation with the IOL-Con software	2-4 Months, & 5-8 Months