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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femtosecond Laser assisted Cataract Surgery | Active Comparator | Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. |
|
| Manual Cataract Surgery | Active Comparator | Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser | Device | Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rupert Menapace, MD | Medical Universitiy of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34135449 | Derived | Reiter GS, Schwarzenbacher L, Schartmuller D, Roggla V, Leydolt C, Menapace R, Schmidt-Erfurth U, Sacu S. Influence of lens opacities and cataract severity on quantitative fundus autofluorescence as a secondary outcome of a randomized clinical trial. Sci Rep. 2021 Jun 16;11(1):12685. doi: 10.1038/s41598-021-92309-6. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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).
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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.
| Manual Cataract Surgery | Other | conventional cataract surgery as control |
|
| 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 |