Age Related Cataracts, Cystoid Macular Edema
Conditions
Brief 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.
Interventions
DEVICEFemtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
conventional cataract surgery as control
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, 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.
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness | Baseline to 6 weeks postoperative | Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of lens density on quantitative autofluorescence | 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 | 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) |
Countries
Austria
Outcome results
None listed