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

Study Overview
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Brief Summary
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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.

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

Conditions
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Age Related Cataracts, Cystoid Macular Edema

Intervention / Treatment
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* Device: Femtosecond Laser
* Other: Manual Cataract Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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 |