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Clinical Trials |

Single-Session vs Multiple-Session Pattern Scanning Laser Panretinal Photocoagulation in Proliferative Diabetic Retinopathy:  The Manchester Pascal Study

Mahiul M. K. Muqit, MRCOphth; George R. Marcellino, PhD; David B. Henson, PhD; Lorna B. Young, MBChB; Niall Patton, FRCOphth; Stephen J. Charles, FRCOphth; George S. Turner, FRCOphth; Paulo E. Stanga, MD
Arch Ophthalmol. 2010;128(5):525-533. doi:10.1001/archophthalmol.2010.60.
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Objective  To investigate the effects of pattern scanning laser (Pascal; OptiMedica, Santa Clara, California) multispot panretinal photocoagulation given in a single-session (SS-PRP) vs single-spot multiple-session PRP (MS-PRP) on proliferative diabetic retinopathy (PDR).

Methods  Single-center, randomized clinical trial of 40 eyes. Proliferative diabetic retinopathy was treated with a 400-μm spot size in 1500 burns given either as Pascal in 20-millisecond SS-PRP or in 3 sessions (100-millisecond MS-PRP) during a 4-week period. Visual acuity, central subfield retinal thickness (CRT), and 24-2 Swedish interactive thresholding algorithm visual fields were recorded at baseline and 4 and 12 weeks.

Main Outcome Measures  Central subfield retinal thickness, mean deviation, and PDR grade at 12 weeks.

Results  There was a significant increase in mean CRT with MS-PRP (22 μm at 4 weeks, 95% CI, −32.25 to −10.75; 20 μm at 12 weeks, 95% CI, −28.75 to −10.82; P < .001) and no significant increase in the SS-PRP group. The mean deviation increased significantly in the SS-PRP group after 4 weeks (0.73 dB, P = .048), with no significant changes in either group at other points. A positive effect on PDR was observed in 74% of eyes in the SS-PRP group vs 53% in the MS-PRP group (P = .31). Mean treatment time for SS-PRP was 5.04 minutes (SD, 1.5 minutes) compared with 59.3 (SD, 12.7 minutes) in the MS-PRP group (P < .001).

Conclusions  There were no adverse outcomes (CRT, visual acuity, or visual field) from using multispot SS-PRP vs single-spot MS-PRP at 12 weeks postlaser, and treatment times were significantly shorter for multispot SS-PRP. Pascal SS-PRP was as effective as MS-PRP in the treatment of PDR.

Application to Clinical Practice  Twenty-millisecond Pascal SS-PRP may be safely and rapidly performed in 1500 burns with a similar efficacy to conventional MS-PRP.

Trial Identifier  Research and Development Office PIN R00037, Central Manchester University Hospitals Foundation Trust.

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Figures

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Figure 1.

Current minimum field of vision for safe driving as defined by the Driving and Vehicle Licensing Authority (United Kingdom). The Esterman visual field is annotated to show at least 120° on the horizontal meridian measured using a target equivalent to the white Goldmann III4e settings. In addition, there should be no significant defect in the binocular field that encroaches within 20° of fixation above or below the horizontal meridian.

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Figure 2.

Flowchart for the study sample.

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Figure 3.

Pascal 20-millisecond single-session panretinal photocoagulation burns within 5 × 5 arrays shown at different times. A, Fundus autofluorescence photograph at 1 hour. B, Color fundus photograph at 1 hour. C, Fundus autofluorescence photograph at 4 weeks showing uniform increased autofluorescence within each pattern array. D, Color fundus photograph at 4 weeks showing localized laser burns. E, Color fundus photograph at 12 weeks showing partially pigmented laser burns within two 5 × 5 pattern arrays.

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Figure 4.

Central retinal thickness alterations over time. The horizontal line in the middle of each box indicates the mean, while the top and bottom borders of the boxes mark the standard error. The whiskers above and below the boxes mark the standard deviation. The triangles are outliers and the diamonds are extremes.

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Figure 5.

Macular volume changes within the central subfield over time. The horizontal line in the middle of each box indicates the mean, while the top and bottom borders of the boxes mark the standard error. The whiskers above and below the boxes mark the standard deviation. The triangles are outliers and the diamonds are extremes.

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Figure 6.

Total macular volume changes over time. The horizontal line in the middle of each box indicates the mean, while the top and bottom borders of the boxes mark the standard error. The whiskers above and below the boxes mark the standard deviation. The triangles are outliers and the diamonds are extremes. ETDRS indicates Early Treatment Diabetic Retinopathy Study.

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Figure 7.

Change in mean deviation of visual field plots over time. The horizontal line in the middle of each box indicates the mean, while the top and bottom borders of the boxes mark the standard error. The whiskers above and below the boxes mark the standard deviation. The triangles are outliers and the diamonds are extremes.

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