Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery

Medical University of Vienna60 enrolled

Overview

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date. Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

Conditions

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation * Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible) Exclusion Criteria: * Corneal abnormality * Preceding ocular surgery or trauma * Uncontrolled glaucoma * Proliferative diabetic retinopathy * Macular degeneration * Iris neovascularization * History of uveitis/iritis * Microphthalmus * Recurrent intraocular inflammation of unknown etiology * Blind fellow eye * Uncontrolled systemic or ocular disease

Outcomes

Primary Outcomes

Central Macular Thickness

Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)

Time frame: Baseline to 6 weeks postoperative

Secondary Outcomes

Influence of lens density on quantitative autofluorescence

Influence of lens density on quantitative autofluorescence will be assessed in qAF units. Images will be recorded after volume scans for each eye on designated visits. Quantitative Autofluorescence quantifies natural fundus autofluorescence with a Spectralis HRA+OCT. This method uses the same wavelength and confocal scanning laser ophthalmoscope as fundus autofluorescence (488nm; maximum power: 280 µW) and can be used to determine the integrity and vitality of the retinal pigment epithelium which is important for nourishment the retina.

Time frame: Baseline to 1 weel, 3 weeks and 6 weeks postoperative