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Multi-spot laser coagulation with the VISULAS 532s VITE : A comparative study of 101 procedures A mono-center clinical study to compare treatment workflow and patient compliance of multi-spot coagulation with the new VISULAS 532s VITE laser in comparison to single- spot laser therapy with the conventional green coagulation laser VISULAS 532s Antje Röckl, MD, Marcus Blum, MD, Department of Ophthalmology, Helios Kliniken Erfurt, Germany ABSTRACT BACKGROUND VISULAS 532s VITE is a 532 nm photocoagulation la- ser which is able to operate both in classic single-spot treatment modes as well as in a new, semi-automated multi-spot treatment mode. In the latter mode, the laser fires a predetermined linear spot sequence at high speed, released with the joystick trigger button of the laser slit lamp. The authors report their early experience with the system and compared the new multi-spot with the con- ventional single-spot functionality. METHODS 101 procedures of pan-retinal photocoagulation (PRP) have been divided into two groups - group A: laser therapy in classic single-spot coagulation with the con- ventional VISULAS 532s, and group B: laser therapy in multi-spot operation using the new functionality of the VISULAS 532s VITE. The shorter pulse duration of 20 ms in multi-spot group B in comparison with 100-150 ms in single-spot group A, has been compensated for by high- er laser power values in order to achieve a comparable, moderate blanching of the retina. RESULTS Compared with the single-spot treatment group, mul- ti-spot coagulation with the VISULAS 532s VITE saves half a minute per 100 applied laser shots in an average PRP session. Depending on the number of laser spots per multi-spot sequence, up to 2/3 of the overall treatment time of an average PRP session can be saved. Whereas 46.0% of patients of single-spot group A have reported feeling some degree of pain during la- ser treatment, only 1.3% of the patients in multi-spot group B have reported feeling pain during their treat- ment. The average pain value in the single-spot coagulation group A was 2.1. In the multi-spot coagulation group B, the average pain value was only 0.1. No adverse events were noted in either of the two groups. INTRODUCTION Laser photocoagulation remains the gold standard in the therapy of many retinal vascular disorders. For more than 30 years, it has been known that panretinal laser photocoagulation (PRP) is effective in treating proliferative retinopathy in a wide variety of underlying conditions, of which diabetic retinopathy is the most common indication. The most frequently used photocoagulation settings are still based on the original recommendations of the DRS study from the late seventies /1/. Classic photocoagula- tion conditions of pulse widths from 100 to 200 ms and laser powers from 200 to 400 mW are still widely recom- mended although commercially available photocoagula- tion lasers have been capable of delivering both shorter
Transcript
  • 1Multi-spot laser coagulation with the VISULAS 532s VITE :A comparative study of 101 proceduresA mono-center clinical study to compare treatment workflow and patient compliance of multi-spot coagulation with the new VISULAS 532s VITE laser in comparison to single-spot laser therapy with the conventional green coagulation laser VISULAS 532s

    Antje Rckl, MD, Marcus Blum, MD, Department of Ophthalmology, Helios Kliniken Erfurt, Germany

    ABSTRACT

    BACKGROUND

    VISULAS 532s VITE is a 532 nm photocoagulation la-ser which is able to operate both in classic single-spot treatment modes as well as in a new, semi-automated multi-spot treatment mode. In the latter mode, the laser fires a predetermined linear spot sequence at high speed, released with the joystick trigger button of the laser slit lamp. The authors report their early experience with the system and compared the new multi-spot with the con-ventional single-spot functionality.

    METHODS

    101 procedures of pan-retinal photocoagulation (PRP) have been divided into two groups - group A: laser therapy in classic single-spot coagulation with the con-ventional VISULAS 532s, and group B: laser therapy in multi-spot operation using the new functionality of the VISULAS 532s VITE. The shorter pulse duration of 20 ms in multi-spot group B in comparison with 100-150 ms in single-spot group A, has been compensated for by high-er laser power values in order to achieve a comparable, moderate blanching of the retina.

    RESULTS

    Compared with the single-spot treatment group, mul-ti-spot coagulation with the VISULAS 532s VITE saves half a minute per 100 applied laser shots in an average PRP session.

    Depending on the number of laser spots per multi-spot sequence, up to 2/3 of the overall treatment time of an average PRP session can be saved. Whereas 46.0% of patients of single-spot group A have reported feeling some degree of pain during la-ser treatment, only 1.3% of the patients in multi-spot group B have reported feeling pain during their treat-ment.The average pain value in the single-spot coagulation group A was 2.1. In the multi-spot coagulation group B, the average pain value was only 0.1.No adverse events were noted in either of the two groups.

    INTRODUCTION

    Laser photocoagulation remains the gold standard in the therapy of many retinal vascular disorders.For more than 30 years, it has been known that panretinal laser photocoagulation (PRP) is effective in treating proliferative retinopathy in a wide variety of underlying conditions, of which diabetic retinopathy is the most common indication. The most frequently used photocoagulation settings are still based on the original recommendations of the DRS study from the late seventies /1/. Classic photocoagula-tion conditions of pulse widths from 100 to 200 ms and laser powers from 200 to 400 mW are still widely recom-mended although commercially available photocoagula-tion lasers have been capable of delivering both shorter

  • 2pulse widths as well as higher laser power for years. For instance, the VISULAS 532s from Carl Zeiss delivers laser pulses with pulse durations from 10 ms to continuous wave, offering a maximum laser power of 1.5 W (mea-sured at the cornea). Recently, Zeiss has implemented the concept of fast and flexible multi-spot cascades in the new VITE option of the VISULAS 532s photocoagulation laser. The purpose of this study was to compare the new multi-spot to the tra-ditional single-spot operation of the VISULAS 532s VITE. One goal was to investigate if and how the improved VITE functionality accelerates photocoagulation work-flow in daily clinical practice in comparison to classic single-spot use. The second goal was to evaluate if and how patient compliance is influenced by the change in the modus operandi.

    METHODS

    PATIENTS

    Only patients whose diagnosis definitely requires a pan-retinal photocoagulation therapy have been recruited for this study. No restrictions regarding the patients race or gender have been postulated. Only patients aged 18 years or older participated in this study. Patients with ocular pathologies such as tremor, cataract, cloudy vitre-ous or acute inflammation have been excluded from this study. Also patients who received a laser treatment with less than 350 burns were retroactively excluded from the study. All patients were treated from June 2009 to Octo-ber 2009.

    Of the group A procedures of the single-spot group, 28 (80%) were for Proliferative Diabetic Retinopathy, 4 (11%) for Central Retinal Artery Occlusion, and 3 (9%) for Central Retinal Vein Occlusion. 7 (20%) of group A treatments were initial first treatments, and 28 (80%) re-treatments (including a second and third PRP session and re-filling procedures).

    Of the group B procedures of the multi-spot group, 50 (75%) were for Proliferative Diabetic Retinopathy, 7 (11%) for Central Retinal Artery Occlusion, and 9 (14%) for Central Retinal Vein Occlusion. 15 (23%) of group B treatments were initial first treatments, and 51 (77%) re-treatments (including both a second / third PRP session and re-filling procedures).

    Group A (non-VITE)Single-spot

    [100 150 ms]

    Group B (VITE)

    Multi-spot [20 ms]

    Number of Procedures 35 66

    Patient Gender Female Male

    49% [17]51% [18]

    33% [22]67% [44]

    Patient AgeMean valueStandard DeviationRange

    6312

    37 90

    6411

    38 88

    Diagnosis Diabetic Retinopathy Central Retinal Artery OcclusionCentral Retinal Vein Occlusion

    80% [28]

    11% [4]

    9% [3]

    76% [50]

    14% [9]

    10% [7]

    Laser Therapy First treatment Re-treatment

    20% [7]80% [28]

    23% [15]77% [51]

    Table 1: Patient demographics

    TREATMENT REGIMEN

    The VISULAS 532s VITE is a frequency-doubled, neodym-ium-doped yttrium aluminum garnet (Nd:YAG) solid-state laser operating at 532 nm wavelength. Besides the clas-sical single-spot treatment mode, the VISULAS 532s VITE is capable of delivering multi-spot sequences at a single press of the release button on the slit lamp joystick. Based on the concept of flexible treatment multi-spot cascades, linear, circular or customized coagulation strategies can be pursued (see Fig. 1). Linear spot sequences of variable orientation consisting of 3 to 8 single laser spots are most suitable for pan-retinal photocoagulation. Semi-automated parallel movement of the slit lamp field and the laser beam in the multi-spot mode allows indi-vidual application of several spots consecutively in fast linear sequences to fill in a large retinal area.During the normal retina consultation hours in the Helios Kliniken Erfurt, all patients were randomly allocated to receive either laser treatment in regimen A or B. In both treatment regimens, a single quadrant of the retina was treated with about 500 peripheral laser spots. In group A, shots of scatter laser photocoagulation using con-ventional laser parameters in the single-spot operation mode were applied: a spot size of 200 m, exposure times between 100 and 150 ms, and laser power values sufficient to cause moderate blanching of the retina were used. In group B, laser treatment was also performed

  • 3with 200 m spot size, but this time in multi-spot opera-tion with a pulse duration of 20 ms. Therefore, higher laser power values had to be used in order to provide a similar visible laser effect in both study groups. For the VITE group B we used straight, linear spot sequences of variable orientation. We decided to use 3 to 6 individual laser spots per sequence with a spacing of a single spot diameter.

    Group A Non-VITE treatmentSingle-spot

    [100 150 ms]

    Group BVITE

    treatmentMulti-spot

    [20 ms]

    Laser spot diameter [m]

    200 200

    Laser power [mW]Mean valueStandard deviationRange

    15688

    70380

    280105

    120600

    Pulse duration [ms]Mean valueStandard deviationRange

    11622

    100 150

    20020

    Number of laser burns Mean valueStandard deviationRange

    50965

    462 609

    55582

    400 837

    Table 2: Treatment parameters

    The treatment of all patients was recorded on video in order to compare treatment times with the two treat-

    ment regimens. The video camera, which was placed on a co-observation tube, was switched on when the pa-tient took a seat, and switched off when the patient left from the chair after treatment. The treatment time was defined as the time from the first to the last applied laser pulse in a treatment session. It was measured after treat-ment on the basis of the acquired video data. Fundus im-ages were acquired after laser treatment with an FF450 fundus camera from Carl Zeiss in order to compare treat-ment regimens regarding the spatial regularity, homoge-neity and intensity of the applied laser spots.

    At the end of the laser treatment, patients were asked to mark on a visual analog, linear scale the severity of the pain experienced for the two treatment regimens with 0 (= no pain) to 10 (= most severe pain ever experienced). The results were presented in terms of mean pain scores and analyzed in terms of standard deviations.

    RESULTS and DISCUSSION

    In the study period, 142 procedures were included. Finally, a complete set of data was available from 101 procedures after exclusion criteria. 35 of them were ap-plied in the single-spot treatment mode (= Group A, non-VITE group), and 66 in the multi-spot treatment mode (= Group B, VITE group).

    The average laser pulse of the 35 conventional treat-ments in the single-spot treatment mode (= Group A,

    Fig. 1: Possible, multi-spot treatment strategies with the

    VISULAS 532s VITE

    Colour fundus image of a multi-spot laser treatment with

    linear cascades of the VISULAS 532s VITE

  • 4non-VITE group) had a duration of 116 ms and a laser power of 157 mW. The average non-VITE treatment consisted of 512 laser burns. The average laser pulse of the 66 treatments in the multi-spot treatment mode (= Group B, VITE group) had a duration of 20 ms and a laser power of 290 mW. The average VITE treatment consisted of 555 laser burns.

    200

    250

    300

    350

    r Pow

    er [m

    W]

    0

    50

    100

    150

    0 20 40 60 80 100 120 140 160

    Aver

    age

    Lase

    r

    Pulse Duration [ms]

    Fig. 2: Average laser power values used depending on laser

    pulse duration

    Fig. 2 displays the average values of the mean laser power values for all applied pulse durations. The applied laser power values in the multi-spot treatment group B had been chosen in such a way that the visible clinical endpoint (the burns) in this group corresponds to the clinical outcomes in group A. Fig. 2 illustrates that shorter laser pulse durations have to be compensated for with higher laser power values. Because of the relatively gen-tle laser powers we used in our single-spot therapy regi-men, this compensation for the shorter 20 ms multi-spot pulses did not cause any clinical side-effects at all.It should be noted that physicians who already coagulate with higher laser powers in conventional treatment may also use 30, 40, or 50 ms pulse durations with the multi-spot option VITE, which require less compensation in the applied laser power. We extracted the individual treatment times from the recorded videos of all laser treatments. Based on the individual treatment times we calculated a normalized treatment time value which represents the individual treatment time normalized to the application of 100 la-ser pulses.

    Group A (non-VITE group)

    Group B(VITE group)

    Number of procedures 35 66

    Treatment time (normalized to 100 burns)

    Mean valueStandard deviationRange

    73.4 sec

    9.6 sec61.6 103.7 sec

    49.4 sec

    14 sec24.0 97.5 sec

    Mann Whitney U-Test P < 0.05

    Table 3: Normalized treatment time statistics in both study

    groups

    Comparing the normalized treatment times in the two study groups, a treatment with 100 laser shots in single-spot treatment group A takes an average of 73.4 sec-onds, a treatment with 100 laser shots in multi-spot treatment group B takes 49.4 seconds on average. This corresponds to a time saving of 24.0 seconds per 100 ap-plied laser shots or a relative time saving of 33% in the multi-spot VITE group B.In order to take into account an initial learning curve when the operator has to become accustomed to the system and gain experience with the new multi-spot sequences, we divided the VITE group B into two subgroups:

    Group B1 contains all multi-spot treatments within the first 8 weeks after installation of the system (June and July 2009). Group B2 contains all multi-spot treatments after week 8 from installation of the same operator (September and October 2009).

    Group B1 (VITE group 8 weeks)

    Number of procedures 29 37

    Treatment time (normalized to 100 burns)

    Mean valueStandard deviationRange

    55.5 sec

    17.0 sec24.0 97.5 sec

    44.8 sec

    9.9 sec27.2 62.3 sec

    Mann Whitney U-Test P < 0.05

    Table 4: Normalized treatment time statistics in both B sub-

    groups

  • 5Comparing the normalized treatment times between the two B sub-groups, a treatment with 100 laser shots with-in the adoption phase of 8 weeks takes 55.5 seconds on average; after an adoption phase it shortens to an aver-age of 44.8 seconds. In other words: on average, a skilled operator of group B2 saves half a minute per 100 applied laser shots with the multi-spot option VITE compared to a skilled single-spot treatment operator. This corresponds to a relative time saving of 40%. Comparing the stan-dard deviation values of the normalized treatment times of groups A, B1 and B2 from tables 3 and 4, these values suggest that after the adoption phase of 8 weeks (with a treatment of approximately 50 eyes), the operator in multi-spot group B2 has gained a similar skill level as in single-spot reference group A based on several years of experience with the VISULAS 532s laser.The normalized treatment time values for all the treat-

    ments within this clinical study are displayed in Fig. 3. The shortest normalized treatment times of about 25 seconds per 100 shots were reached in both B sub-groups. The longest normalized treatment time of about 95 seconds in group B1 was significantly reduced to about 60 sec-onds in group B2 after the adoption phase of 8 weeks. Therefore, the linear interpolation curve of the normal-ized treatment values of groups B2 shows an identical slope to the line of single-spot group A, visualizing simi-lar skill levels of the operator in both groups. Both the faster individual treatments (left-hand side of the graph) and the slower individual treatments (right-hand side of the graph) of multi-spot treatment group B2 show the same time saving of half a minute in comparison with a comparable treatment procedure in single-spot treat-ment group A.

    60

    80

    100

    120

    t tim

    e fo

    r 100

    lase

    r sho

    ts

    0

    20

    40

    0 5 10 15 20 25 30 35 40

    Nor

    mal

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    trea

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    t

    Patient Number

    Group A (skilled) Group B1 (< 8w) Group B2 (> 8w)

    Linear (Group A (skilled)) Linear (Group B1 (< 8w)) Linear (Group B2 (> 8w))

    Fig. 3: Comparison of the normalized treatment times of groups A, B1 and B2

    Generally, initial PRP sessions on patients with good com-pliance take the shortest normalized treatment times, whereas re-filling procedures and patients with weak compliance slow down the PRP treatment workflow. When working with the multi-spot option VITE, even the most demanding treatments have a comparable or short-

    er normalized treatment time than the fastest single-spot therapy outcomes. The therapy workflow can be flexibly adjusted to the individual patient case by variation of the spot sequence length. Table 5 shows the statistics of spot sequence lengths used within the treatment group B2:

  • 6Number of laser spots per spot-sequence

    Patients

    3 only 3 % [1]

    3 and 4 3 % [1]

    4 only 11 % [4]

    4 and 5 8 % [3]

    5 only 53 % [20]

    5 and 6 3 % [1]

    6 only 8 % [3]

    More than 2 changes between 3, 4, 5, 6 spots (mostly re-filling)

    11 % [4]

    Table 5: Statistics of applied multi-spot sequences in Group B

    after 8 weeks

    Based on these statistics, Fig. 4 shows the dependency of the normalized treatment time from the length of the applied spot-sequence. In this figure, we have considered treatments with a single sequence length value as well as treatments where we switched between two length val-ues. Preferably, we treated with 5 spots per sequence in order to have a similar confidence level and control as we did in the past with single-spot laser treatment. Sequen-ces of 2 spots only provide minor workflow acceleration. Large sequences of 7 or 8 spots could be beneficial for initial PRP treatments. In our study, however, we stayed with our very controlled way of operation, which makes it more comfortable and easy both for the operator as well as for the patient. The linear interpolation curve of Fig. 4 shows a clear trend: The larger the spot sequence length, the shorter the normalized treatment time. Treat-ments which alternated between two spot sequence lengths required slightly longer normalized treatment times because of the need to switch between the dif-ferent spot sequence length values. Therefore, they are generally situated above the interpolation line. Although not experimentally proven in this study, an extrapolation of the linear regression line to the largest available spot sequence length value of 8 spots suggest that it may be possible to shorten the normalized treat-ment time to an average of 20 to 25 seconds per 100 applied laser spots.

    40

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    aliz

    ed tr

    eatm

    ent t

    ime

    00 la

    ser s

    hots

    0

    10

    20

    30

    40

    1,0 2,0 3,0 4,0 5,0 6,0 7,0 8,0

    Aver

    age

    norm

    per 1

    0

    Laser spots per spot sequence

    Fig. 4: Dependency of average normalized treatment time from

    the length of a multi-spot sequence

    Pain response during laser photocoagulation is variable among patients and also depends on the treated area on the retina. However, discomfort remains an impor-tant cause of unsatisfactory treatment sessions for both patient and physician. Strategies to make the treatment more comfortable include changing of the laser param-eters. The results of a small study in the 1990s showed that patients found shorter exposure, higher power laser treatment much more comfortable than conventional settings with no apparent reduction in visible endpoint. A more recent study on 20 patients has clearly proven that reducing the exposure time and increasing the laser power reduced pain significantly without compromising the long-term results of the laser therapy /3/. Shorter du-ration laser burns may be less painful due to the thermal conduction effects in the treated tissue. Short-duration burns cool off more rapidly in comparison with the longer duration burns, in which adjacent tissues become heated and the energy reaches the pain-sensitive region in the deeper retinal and choroidal layers.When applying multi-spot sequences either by the press of the laser slit lamp joystick or the footswitch pedal, the overall treatment time of a sequence should not signifi-cantly exceed half a second in order to avoid interference with eye movements of the patients. Therefore, when using multi-spot sequences with the VISULAS 532s VITE, the pulse duration of the individual laser pulses within a sequence is limited to 2050 ms. In our clinical study, we used significantly shorter pulse durations in multi-spot group B than in single-spot group A, which had to be compensated for by laser power (see Table 1).

  • 7In order to investigate the pain perception connected with the different laser treatment regimens in both groups, we defined a graphical linear scale on which we defined de-grees of perceived pain from 0 (= no pain) to 10 (= severe pain). Patients were shown this scale right after the laser treatment and asked to score the perceived pain value. 16 (46.0%) out of the 35 patients of group A scored a value greater than zero, which indicated some degree of pain during the laser treatment. The statistics of the pain response of the single-spot treatment group A is shown in figure 5.2 (1.3%) of the 66 patients of group B reported pain after treatment with the multi-spot option VITE, with one scoring a value of 3 and one a value of 4. All other pa-tients of group B had no pain at all during the multi-spot treatment.

    12

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    atie

    nts

    0

    2

    4

    6

    8

    10

    0 1 2 3 4 5 6 7 8 9 10

    Num

    ber o

    f pa

    Pain score

    Fig. 5: Pain score statistics of single-spot treatment group A

    The results confirm the findings in /3/ that reducing the exposure time and increasing the laser power can reduce pain significantly without compromising the long-term results of the treatment. Due to the shorter pulse du-ration, there is a reduced thermal diffusion to adjacent retinal and choroidal layers which prevents a heating of the pain-sensitive areas.

    CONCLUSION

    In this study, we treated 35 patients in single-spot treat-ment with the VISULAS 532s and 66 patients with the new multi-spot option of the VISULAS 532s VITE.Compared to conventional single-spot photocoagulation, laser treatment with the VISULAS 532s VITE significantly reduces the overall treatment time while shorter pulse durations improve patients pain perception. Our results suggest that after a learning phase of 8 weeks with a VITE multi-spot treatment of approximately 50 eyes, an operator can gain the same degree of routine as a skilled single-spot user with more than 4 years of experience.Compared with the single-spot treatment group, multi-spot coagulation with the VISULAS 532s VITE saves half a minute per 100 applied laser shots in an average PRP ses-sion. Depending on the number of laser spots per multi-spot sequence, up to 2/3 of the overall treatment time of an average PRP session can be saved. Although rapid laser treatment with multi-spot cascades requires short individual pulse durations, which have to be compensated for with higher laser power, no adverse side-effects have been observed during the multi-spot treatment sessions with the VISULAS 532s VITE. On the contrary, only 2 patients (1.3%) treated with the VISULAS 532s VITE in the multi-spot group reported feel-ing pain, whereas 16 patients (46.0%) patients treated in the conventional way reported feeling pain during the laser treatment.

  • 8Carl Zeiss Meditec AG

    Goeschwitzer Str. 5152

    07745 Jena

    GERMANY

    Phone: +49 3641 220 333

    Fax: +49 3641 220 112

    [email protected]

    www.meditec.zeiss.com

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    REFERENCES

    /1/ The Diabetic Retinopathy Study Research Group: Photocoagulation treatment of proliferative diabetic retinopathy: The second report from the Diabetic Reti-nopathy Study. Arch Ophthalmol 1978; 85: 81106.

    /2/ Friberg et al.: Alteration of pulse configuration af-fects the pain response during diode laser, Lasers Surg Med 16, 1995, 380-383.

    /3/ Al-Hussainy et al.: Pain response and follow-up of patients undergoing pan-retinal laser photocoagulation with reduced exposure times, Eye 22, 2008, 96-99.


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