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

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

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 Overview

• Status: Unknown
• Conditions: Age Related Cataracts; Cystoid Macular Edema
• Intervention / Treatment: Device: Femtosecond Laser; Other: Manual Cataract Surgery

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femtosecond Laser assisted Cataract Surgery; Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.	Device: Femtosecond Laser; Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
Active Comparator: Manual Cataract Surgery; Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.	Other: Manual Cataract Surgery; conventional cataract surgery as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Macular Thickness	Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)	Baseline to 6 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 1 weel, 3 weeks and 6 weeks postoperative
Central Macular Thickness	Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)	Baseline to 1 week, 3 weeks, 6 weeks postoperative

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rupert Menapace, MD, Medical Universitiy of Vienna

Publications and helpful links

General Publications

• Reiter GS, Schwarzenbacher L, Schartmuller D, Roggla V, Leydolt C, Menapace R, Schmidt-Erfurth U, Sacu S. Influence of lens opacities and cataract severity on quantitative fundus autofluorescence as a secondary outcome of a randomized clinical trial. Sci Rep. 2021 Jun 16;11(1):12685. doi: 10.1038/s41598-021-92309-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): February 19, 2019
• Study Completion (Anticipated): April 6, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Lens Diseases; Macular Edema; Cataract
• Other Study ID Numbers: 1053/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No