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

Medical University of Vienna

Status: Unknown

Conditions: Age Related Cataracts; Cystoid Macular Edema

Treatments: Device: Femtosecond Laser; Other: Manual Cataract Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03465124

1053/2018

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Femtosecond Laser assisted Cataract Surgery

Active Comparator group

Description:

Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.

Treatment:

Device: Femtosecond Laser

Manual Cataract Surgery

Active Comparator group

Description:

Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.

Treatment:

Other: Manual Cataract Surgery