Senile Cataract

Cataract

FLACS USFREE

Traditional phacoemulsification cataract surgery using ultrasound.

Traditional Surgery

Efficacy of FLACS USFREE Compared to Traditional Surgery Using Ultrasound.

Randomized, Controlled Trial in Patients With Senile Cataract to Evaluate the Efficacy of Ultrasound-free Femtosecond Laser (FLACS) Cataract Surgery (USFREE), Compared to Traditional Phacoemulsification Surgery Using Ultrasound.

Difference in BSS (balanced saline solution) volume observed between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.
The volume of BSS will be measured during surgery in mL, the sum of the BSS volume observed will be compared between the 2 groups. This volume will be monitored and measured by the Centurion® phacoemulsification device.

Cumulative dissipated energy is an estimate of the energy used at the incision site during cataract removal and is measured automatically by the Centurion® device in% -seconds. Lower value reflects less energy used, being considered more favorable for the safety of the corneal endothelium.
For surgeries that occurred according to the first version of this protocol (03-Nov-2015) the CDE data contained in the source documents will be used, , since this is a data already collected during both procedures.

Phacoemulsification time is measured automatically by Centurion®, and expressed in minutes and seconds.

The endothelial cell count will be performed in each eye at V1, V1, V2 and V3 (and V5, V6 and V7 for O2) using SP02® specular microscope (CSO, Italy).

Difference in visual acuity presented 1, 7 and 30 days after cataract surgery between eyes submitted to FLACS USFREE versus traditional phacoemulsification with ultrasound surgery.

The visual acuity presented and best corrected will be measured in V-1, V1, V2 and V3 for each eye (and V5, V6 and V7 for O2).
Assessment of visual acuity in the distance (4 m) will be performed with the standardized and backlit LogMAR table. All exams for this study will be performed with the same equipment and lighting conditions. Research participants will be asked to read the smaller line whose letters are easily distinguishable. Survey participants will continue to read lines with smaller and smaller letters until the survey participant misses all the letters or can not guess any of them. While the survey participant reads the table, the number of letters read incorrectly will be recorded on each line. In this study, the LogMAR of the presented visual acuity and the visual acuity with better correction will be obtained.

Simulated keratometry (Yes K) will be measured in each eye at V-1, V1, V2 and V3 (and V5, V6 and V7 for O2) using the Pentacam® system (OCULUS, WA, USA). The Pentacam® system will use a rotating Scheimpflug camera to produce a three-dimensional analysis of the anterior segment of the cornea. A Sim K will be obtained by averaging the power of the anterior surface of the cornea along a 3 mm center ring, measured in diopters (D). In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

In this examination, the pachymeter will be placed in front of the eye to measure the thickness of the cornea, which will be recorded in mm. This analysis will be done in V-1, V1, V2 and V3 (and V5, V6 and V7 for O2). In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

Intraocular pressure will be measured in each eye at V-1, V1, V2 and V3 (and V5, V6 and V7 for O2) using the Goldmann aplanation tonometer (Haag-Streit Diagnostics, Switzerland). The intraocular pressure will be measured in mmHg. In order to minimize bias, measurements will always be made on the same device, with the same operator or their back-up, both with the same training.

Adverse events will be gathered for each eye and each research participant

microphthalmos/edema

Efficacy of FLACS USFREE Compared to Traditional Surgery Using Ultrasound.

Најкомплетната база на податоци за лековити билки поддржана од науката