An interventional study of Femtosecond Laser and Manual Cataract Surgery in Age Related Cataracts and Cystoid Macular Edema, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.
Device: Femtosecond Laser
Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.
Other: Manual Cataract Surgery
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
conventional cataract surgery as control
Central Macular Thickness
Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
Time frame: Baseline to 6 weeks postoperative
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.
Time frame: 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)
Time frame: Baseline to 1 week, 3 weeks, 6 weeks postoperative
Plan to share: No
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Medical University of Vienna