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PASCAL® Endpoint Management Treatment Guidelines

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Management PASCAL® Endpoint Management Treatment Guidelines
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Page 1: PASCAL® Endpoint Management Treatment Guidelines

Ma n a g em e n t

PASCAL® Endpoint Management™

Treatment Guidelines

Page 2: PASCAL® Endpoint Management Treatment Guidelines

Endpoint Management (EpM) is a proprietary software that uses a unique algorithm to automatically adjust laser energy (power and pulse duration) applied to the eye to deliver tissue-sparing laser treatment. With EpM, everything except for titration power is preset: spot diameter, spacing, energy relative to titration, and pulse duration. All the physician needs to do is to titrate power to a barely visible burn, switch the setting to 30% energy on the EpM scale, and treat. This tissue-sparing technology provides freedom to treat closer to the fovea without fear of causing retinal damage or vision loss.

EpM applies advanced algorithms to deliver sub-visible laser applications that stay within therapeutic boundaries.

Introduction to Endpoint Management (EpM)

HSP expression in laser spots with 100% energy (barely visible burns) on the left and with 30% energy on the right. Note the presence of HSP-70 at the periphery of the 100% traditional laser burns (surrounding the center of cell death) in contrast to the 30% energy burn where HSP-70 is expressed in the entire burn area (indicating little-to-no cell death).

100% 30%

Area of Heat-Shock Protein (HSP) Expression

Page 3: PASCAL® Endpoint Management Treatment Guidelines

Titration Explanation and Protocol

When using EpM, the user first titrates to a comfortable visible endpoint. Establishing a titration endpoint is important as it gives a consistent baseline, ensuring repeatable results between patients.

White arrow - Shows titration to a barely visible burn placed outside the arcades at 100% power.

Black arrow - Landmark reference points for visible feedback and positioning of treated areas.

Begin treatment by titrating to a barely visible burn placed outside the arcades.

Work upwards in small increments until a barely visible burn is seen after about 3 seconds. This power setting is considered your 100%.The 100% level can be used for the landmarks on the edges of the grid patterns.

After the first sight of a barely visible burn, the percentage of energy desired and the parameters are set to 30%.

Titration Protocol: Titration Settings: Exposure: 15 ms

Spot Size: 200 µm

Power: Start at 100 mW for titration burn (100%)

Lens: Volk, Area Centralis or Ocular, Mainster

Tip:

The titration feature allows for a treatment baseline to be established based on the desired tissue response for the intended treatment and therefore should always be done prior to beginning actual treatment. Initial titration setting levels should be low, progressively moving up to achieve the desired response. Titration burns should only be delivered outside the visual field to the outer retina. It is recommended that the physician wait at least 3 seconds before evaluating the titration lesions as this is the time it take to achieve the maximum response.

Page 4: PASCAL® Endpoint Management Treatment Guidelines

Suggested Parameters and Treatment Area

Image is not from actual patient

The following treatment suggestions are based upon clinical studies and physician reported cases.1-4 Topcon does not purport any treatment instructions. For more information, please refer to the PASCAL laser operator manual.

Tip:

IMPORTANT - increase the number of spots to activate the RPE. You can augment the enhanced octants pattern with 4x4 grid patterns outside the enhanced octants. Also with EpM turned on, 2x2 grid patterns are helpful inside the enhanced octants to treat closer to the fovea or to fill in areas. It is recommended that treatment is within a 500 micron radius from the center of the fovea.

Users of laser photocoagulation will notice a difference with EpM, as there will be no evidence of a burn after treatment that is noticeable on FA, OCT, or by clinical assessment. However, the absence of visible treatment scars does not mean that nothing has occurred.

Treatment Patterns and Area:

The patterns on this fundus photo are shown to give the physician a visual reference of where the treatment can be done. During actual EpM treatment, it is the physician’s preference whether to treat with burns that are barely visible or completely invisible, with the exception of Landmark™ patterns (optional) that must be visible to demarcate the boundaries of the treatment pattern.

4x4 grid used outside the enhanced octants pattern

Enhanced Octants 2x2 grid

used to fill where needed

Safety Zone: 500 microns (radius) from the center of the fovea

Spot Size: 200 μm Spacing: 0.25 Exposure: 15 ms

Treatment Parameters:Average Power: 120 mW for titrated burn (100%)

Exposure: 15 ms

Spot Size: 200 µm

Spacing: 0.25 spot diameter

EpM Setting: 30%

Landmark Setting: On (Enhanced Octants, 4x4,  3x3) Off (2x2)

Recommended Lens*: Volk, Area Centralis or  Ocular, Mainster

*Do not use any contact lens with a laser spot magnification of <0.94. Do not use wide field contact lenses. Wide field lenses will enlarge the spot diameter and alter the Foveal Exclusion Zone ring diameter.

Page 5: PASCAL® Endpoint Management Treatment Guidelines

Treatment Parameters:Wavelenth: 577 NM

Power: 120 mW for titrated burn (100%)

Exposure: 15 ms

Spot Size: 200 µm

Spacing: 0.25 spot diameter

Lens: Area Centralis lens

EpM Setting: 30%

Pattern Selection: 4 x 4, 2 x 2, Enhanced Octants

Landmark: On (Enhanced Octants): Off (4x4 & 2x2)

Total spots: 420

Treatment Time: 2 min

EpM Retreatment: One retreatment

Patient Cases - Diabetic Macular Edema

Patient Information: 33-year-old with type 1 diabetes for 20 years. Patient

had decreased visual acuity in both eyes and expressed concern over using anti-VEGF as treatment.

Treatment Parameters:Wavelenth: 577 NM

Power: 120 mW for titrated burn (100%)

Exposure: 15 ms

Spot Size: 200 µm

Spacing: 0.25 spot diameter

Lens: Area Centralis lens

EpM Setting: 30%

Pattern Selection: Enhanced Octants 4x4 and 2x2

Landmark: Off

Total spots: 630

Treatment Time: 2 min

EpM Retreatment: Every 4 to 6 months

Patient Information: 64-year-old female with type 2 diabetes for 20+ years. Severe nonproliferative diabetic retinopathy with macular edema OU. Patient received one intravitreal injection of Ranibuzumab. She had a panic attack during the procedure and refused additional injections.

Before EpM | VA 20/60 4 Years after EpM | VA 20/20

No additional injections

Clinical case courtesy of Dr. Daniel Lavinsky | Porto Alegre, Rio Grande do Sul, BrazilThis case is for informational purposes only from Dr. Lavinsky and does not purport any treatment instructions for use by Topcon Medical Laser Systems, Inc.

Before EpM | VA 20/40 1 Year After EpM | VA 20/20

Page 6: PASCAL® Endpoint Management Treatment Guidelines

Patient Cases - Central Serous Retinopathy2

Patient Information: 61-year-old female. Visual acuity 20/60 OS for more

than 6 months with some sub-foveal leakage in the CSC. No use of steroids or other systemic medication.

Treatment Parameters:Wavelenth: 577 NM

Power: 120 mW for titrated burn (100%)

Exposure: 15 ms

Spot Size: 200 µm

Spacing: 0.25 spot diameter

Lens: Area Centralis lens

EpM Setting: 30%

Pattern Selection: 4 x 4, 2 x 2, Enhanced Octants

Landmark: On (Enhanced Octants): Off (4x4 & 2x2)

Total spots: 520

Treatment Time: 3 minutes

EpM Retreatment: One retreatment after 4 months

Before EpM | VA 20/60 3 Years After EpM |VA 20/20

Clinical case courtesy of Dr. Daniel Lavinsky | Porto Alegre, Rio Grande do Sul, BrazilThis case is for informational purposes only from Dr. Lavinsky and does not purport any treatment instructions for use by Topcon Medical Laser Systems, Inc.Central Serous Retinopathy is not a cleared indication for PASCAL lasers.

Page 7: PASCAL® Endpoint Management Treatment Guidelines

Clinical case courtesy of Dr. Daniel Lavinsky | Porto Alegre, Rio Grande do Sul, BrazilThis case is for informational purposes only from Dr. Lavinsky and does not purport any treatment instructions for use by Topcon Medical Laser Systems, Inc.Central Serous Retinopathy is not a cleared indication for PASCAL lasers.

Patient Cases - Central Serous Retinopathy2

Patient Information: 27-year-old male. Denied use of steroids or other

medications. Came in at month 1 with VA 20/25 and decided to wait on treatment to see if CSR would resolve on its own. At 3 months, VA was 20/40.

Treatment Parameters:Wavelenth: 577 NM

Power: 120 mW for titrated burn (100%)

Exposure: 15 ms

Spot Size: 200 µm

Spacing: 0.25 spot diameter

Lens: Area Centralis lens

EpM Setting: 30%

Pattern Selection: 4 x 4, 2 x 2, Enhanced Octants

Landmark: On (Enhanced Octants): Off (4x4 & 2x2)

Total spots: ~350

Total Treatment Time: 3 minutes

EpM Retreatment: No retreatment

Before EpM | VA 20/40 1 Year After Epm | VA 20/20

Page 8: PASCAL® Endpoint Management Treatment Guidelines

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References

1. Lavinksy D, Wang J, Huie P, et al. Nondamaging Retinal Laser Therapy: Rationale and Applications to the Macula. Invest Ophthalmol Vis Sci. 2016;57:2488–2500

2. Lavinsky D, Palanker, D. Nondamaging photothermal therapy for the retina: initial clinical experience with chronic central serous retinopathy. Retina, The Journal of Retinal and Vitreous Diseases. 2014:1-10

3. Wood E, Karth P, Sanislo S, et al. Nondamaging retinal laser therapy for treatment of central serous chorioretinopathy: What is the evidence? Retina, The Journal of Retinal and Vitreous Diseases. 2016:1-13

4. Wang J, Quam Y, Palanker D. Comparison of continuous-wave and micropulse modulation in retinal laser therapy: Invest Ophthalmol Vis Sci. 2017;58:4722-4732

Clinical cases are courtesy of Daniel Lavinsky, MD. Professor of Ophthalmology at Federal University of Rio Grande do Sul, Brazil. Financial disclosure: Consultant (Topcon).

Patient cases, parameters and techniques provided by the physician/author.

Topcon assumes no responsibility for patient outcomes or for physician oversight.


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