NCT03465124

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Age Related Cataracts
• Cystoid Macular Edema

Interventions

Type	Name	Description
DEVICE	Femtosecond Laser	Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
OTHER	Manual Cataract Surgery	conventional cataract surgery as control

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-02-19
• Completion: 2019-04-06
• First posted: 2018-03-14
• Last updated: 2019-03-07

Locations

1 site across 1 country: Austria