Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery (FLAME)
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|ClinicalTrials.gov Identifier: NCT03465124|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : March 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Age Related Cataracts Cystoid Macular Edema||Device: Femtosecond Laser Other: Manual Cataract Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.|
|Official Title:||Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME|
|Actual Study Start Date :||March 26, 2018|
|Actual Primary Completion Date :||February 19, 2019|
|Estimated Study Completion Date :||April 6, 2019|
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
- Central Macular Thickness [ Time Frame: Baseline to 6 weeks postoperative ]Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
- Influence of lens density on quantitative autofluorescence [ Time Frame: Baseline to 1 weel, 3 weeks and 6 weeks postoperative ]
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.
- Central Macular Thickness [ Time Frame: Baseline to 1 week, 3 weeks, 6 weeks postoperative ]Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465124
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Rupert Menapace, MD||Medical Universitiy of Vienna|