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© 2024 EXCEL-LENS, Inc.
2316 Orchard Parkway
Tracy, CA 95377, USA
EXCEL-LENS, Inc. is a U.S. FDA Registered company and ISO 13485:2016 certified developer and manufacturer of medical devices.
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What is the mechanism of action?
Can you adjust the size of the capsulotomy?
The capsulotomy range can be selected from 4.0 to 5.5 mm in 0.1 mm increments.
What is the impact of a small pupil?
Has miosis been observed?
Miosis was not observed in any of the clinical studies.
What impact can CAPSULaser have on the iris?
In preclinical studies, where the iris was intentionally targeted to determine the consequences of an inadvertent laser interaction, the following reaction was documented:
Why is trypan blue required?
CAPSULaser will not interact with transparent tissue. The capsule needs to be stained with a dye to provide the selective target which only CAPSULBlue provides.
The CAPSULaser technique requires two simultaneous conditions to create a capsulotomy: first a CAPSULBlue stained capsule, and second, the treatment laser focused on the capsule.
Is CAPSULaser similar to a femtosecond laser?
No, it is a continuous-wave laser that is always on during the selective laser capsulotomy treatment. It is not a pulsed laser like the femtosecond laser.
How does CAPSULaser differ from FLACS?
There are many differences between CAPSULaser and FLACS.
Surgical benefits:
What color is the laser?
The laser wavelength is at the peak spectral absorption for CAPSULBlue. The wavelength is in the orange-red range of the spectrum.
Why use this specific formulation of trypan blue?
CAPSULBlue is optimized for consistent staining of the anterior capsule and for absorption of the wavelength of CAPSULaser. This leads to consistent capsulotomies. It is the only version of trypan blue that has been formulated for selective laser capsulotomy.
Does the endothelium also absorb trypan blue?
For cataract surgery trypan blue selectively stains the lens capsule and non-living cells. Healthy corneal endothelial cells are not stained in vivo, as the cellular membrane naturally prevents dye absorption from the posterior surface.
Corneal surgical techniques, such as DSEK, are different and the donor tissue can be stained with dye through in vitro application via the anterior surface of the membrane. CAPSULBlue is not currently indicated for use in DSEK surgery.
Why does the capsulotomy rim appear to be darker blue?
SEM (scanning electron microscopy) images show that the capsule with a “rolled-over” edge, consequently the two layers of tissue at the rim present a darker blue color. This enhances visualization for the remaining steps of the cataract procedure.
How does the capsulotomy rim compare to manual and FLACS?
The “rolled-over” characteristic of the edge created by CAPSULaser generates a strong capsulotomy that is resistant to tearing.
Are there long-term effects of trypan blue?
In surgery over 90% of the CAPSULBlue is removed by rinsing unabsorbed dye and extraction of the stained capsular disk during surgery. The remaining trypan blue (CAPSULBlue) washes out of the eye naturally within a few hours following surgery.
On a global basis, trypan blue is used in over 10% of cataract surgeries for complex cataract cases and training. Trypan blue has a great safety profile as reported in the peer-review literature and the FDA MAUDE database.
Is the capsulotomy going to contract over time with fibrosis?
At 12 months and longer-term follow-up, fibrosis has not been observed.
Why do you recommend/provide a specific viscoelastic?
The high optical quality of CAPSULVisc sodium hyaluronate enhances the performance of CAPSULaser and is proven to deliver consistent outcomes.
Can CAPSULaser treat intumescent cataracts?
Yes, during clinical evaluation hyper-mature cataracts were treated whilst avoiding anterior tears. The use of CAPSULVisc balances the pressure in the intumescent capsule and provides a stable anterior chamber for the laser to act.
Why is a Patient Interface (PI) lens used?
The Patient Interface allows the surgeon to stabilize the eye and center the capsulotomy on the visual axis.
What temperature effects are there during a CAPSULaser procedure?
The CAPSULaser technique is a Selective Laser Capsulotomy approach that only causes a local thermal effect in the lens capsule.
Is CAPSULaser safe for the Retina?
Yes, it complies with all appropriate laser safety standards: FDA CDRH 21CFR1040; IEC 60825-1; ANSI Z136.1-2014; ISO 15004-2, 2007.