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

Cystoid Macular Edema Clinical Trial

— FLAME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03465124
• Other study ID #: 1053/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: April 6, 2019

Study information

• Verified date: March 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 6, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract
• Cystoid Macular Edema
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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