Umut Arslan1, Emin Özmert2, Sibel Demirel3,4, Firdevs Örnek1, Figen Şermet2. 1. Department of Ophthalmology, Ankara Training and Research Hospital, Ankara, Turkey. 2. Faculty of Medicine, Department of Ophthalmology, Ankara University, Ankara, Turkey. 3. Faculty of Medicine, Department of Ophthalmology, Ankara University, Ankara, Turkey. drsibeldemireltr@yahoo.com.tr. 4. Cebeci Tıp Fakültesi, Vehbi Koç Göz hastanesi, Göz Hastalıkları Ana Bilimdalı, Mamak caddesi, Dikimevi/Ankara, Dikimevi/Ankara, Turkey. drsibeldemireltr@yahoo.com.tr.
Abstract
PURPOSE: One of the main reasons for apoptosis and dormant cell phases in degenerative retinal diseases such as retinitis pigmentosa (RP) is growth factor withdrawal in the cellular microenvironment. Growth factors and neurotrophins can significantly slow down retinal degeneration and cell death in animal models. One possible source of autologous growth factors is platelet-rich plasma. The purpose of this study was to determine if subtenon injections of autologous platelet-rich plasma (aPRP) can have beneficial effects on visual function in RP patients by reactivating dormant photoreceptors. MATERIAL AND METHODS: This prospective open-label clinical trial, conducted between September 2016 and February 2017, involved 71 eyes belonging to 48 RP patients with various degrees of narrowed visual field. Forty-nine eyes belonging to 37 patients were injected with aPRP. A comparison group was made up of 11 patients who had symmetrical bilateral narrowed visual field (VF) of both eyes. Among these 11 patients, one eye was injected with aPRP, while the other eye was injected with autologous platelet-poor plasma (aPPP) to serve as a control. The total duration of the study was 9 weeks: the aPRP or aPPP subtenon injections were applied three times, with 3-week intervals between injections, and the patients were followed for three more weeks after the third injection. Visual acuity (VA) tests were conducted on all patients, and VF, microperimetry (MP), and multifocal electroretinography (mfERG) tests were conducted on suitable patients to evaluate the visual function changes before and after the aPRP or aPPP injections. RESULTS: The best-corrected visual acuity values in the ETDRS chart improved by 11.6 letters (from 70 to 81.6 letters) in 19 of 48 eyes following aPRP application; this result, however, was not statistically significant (p = 0.056). Following aPRP injections in 48 eyes, the mean deviation of the VF values improved from - 25.3 to - 23.1 dB (p = 0.0001). Results regarding the mfERG P1 amplitudes improved in ring 1 from 24.4 to 38.5 nv/deg2 (p = 0.0001), in ring 2 from 6.7 to 9.3 nv/deg2 (p = 0.0301), and in ring 3 from 3.5 to 4.5 nv/deg2 (p = 0.0329). The mfERG P1 implicit times improved in ring 1 from 40.0 to 34.4 ms (p = 0.01), in ring 2 from 42.5 to 33.2 ms (p = 0.01), and in ring 3 from 42.1 to 37.9 ms (p = 0.04). The mfERG N1 amplitudes improved in ring 1 from 0.18 to 0.25 nv/deg2 (p = 0.011) and in ring 2 from 0.05 to 0.08 nv/deg2 (p = 0.014). The mfERG N1 implicit time also improved in ring 1 from 18.9 to 16.2 ms (p = 0.040) and in ring 2 from 20.9 to 15.5 ms (p = 0.002). No improvement was seen in the 11 control eyes into which aPPP was injected. In the 23 RP patients with macular involvement, the MP average threshold values improved with aPRP injections from 15.0 to 16.4 dB (p = 0.0001). No ocular or systemic adverse events related to the injections or aPRP were observed during the follow-up period. CONCLUSION: Preliminary clinical results are encouraging in terms of statistically significant improvements in VF, mfERG values, and MP. The subtenon injection of aPRP seems to be a therapeutic option for treatment and might lead to positive results in the vision of RP patients. Long-term results regarding adverse events are unknown. There have not been any serious adverse events and any ophthalmic or systemic side effects for 1 year follow-up. Further studies with long-term follow-up are needed to determine the duration of efficacy and the frequency of application.
PURPOSE: One of the main reasons for apoptosis and dormant cell phases in degenerative retinal diseases such as retinitis pigmentosa (RP) is growth factor withdrawal in the cellular microenvironment. Growth factors and neurotrophins can significantly slow down retinal degeneration and cell death in animal models. One possible source of autologous growth factors is platelet-rich plasma. The purpose of this study was to determine if subtenon injections of autologous platelet-rich plasma (aPRP) can have beneficial effects on visual function in RPpatients by reactivating dormant photoreceptors. MATERIAL AND METHODS: This prospective open-label clinical trial, conducted between September 2016 and February 2017, involved 71 eyes belonging to 48 RPpatients with various degrees of narrowed visual field. Forty-nine eyes belonging to 37 patients were injected with aPRP. A comparison group was made up of 11 patients who had symmetrical bilateral narrowed visual field (VF) of both eyes. Among these 11 patients, one eye was injected with aPRP, while the other eye was injected with autologous platelet-poor plasma (aPPP) to serve as a control. The total duration of the study was 9 weeks: the aPRP or aPPP subtenon injections were applied three times, with 3-week intervals between injections, and the patients were followed for three more weeks after the third injection. Visual acuity (VA) tests were conducted on all patients, and VF, microperimetry (MP), and multifocal electroretinography (mfERG) tests were conducted on suitable patients to evaluate the visual function changes before and after the aPRP or aPPP injections. RESULTS: The best-corrected visual acuity values in the ETDRS chart improved by 11.6 letters (from 70 to 81.6 letters) in 19 of 48 eyes following aPRP application; this result, however, was not statistically significant (p = 0.056). Following aPRP injections in 48 eyes, the mean deviation of the VF values improved from - 25.3 to - 23.1 dB (p = 0.0001). Results regarding the mfERG P1 amplitudes improved in ring 1 from 24.4 to 38.5 nv/deg2 (p = 0.0001), in ring 2 from 6.7 to 9.3 nv/deg2 (p = 0.0301), and in ring 3 from 3.5 to 4.5 nv/deg2 (p = 0.0329). The mfERG P1 implicit times improved in ring 1 from 40.0 to 34.4 ms (p = 0.01), in ring 2 from 42.5 to 33.2 ms (p = 0.01), and in ring 3 from 42.1 to 37.9 ms (p = 0.04). The mfERG N1 amplitudes improved in ring 1 from 0.18 to 0.25 nv/deg2 (p = 0.011) and in ring 2 from 0.05 to 0.08 nv/deg2 (p = 0.014). The mfERG N1 implicit time also improved in ring 1 from 18.9 to 16.2 ms (p = 0.040) and in ring 2 from 20.9 to 15.5 ms (p = 0.002). No improvement was seen in the 11 control eyes into which aPPP was injected. In the 23 RPpatients with macular involvement, the MP average threshold values improved with aPRP injections from 15.0 to 16.4 dB (p = 0.0001). No ocular or systemic adverse events related to the injections or aPRP were observed during the follow-up period. CONCLUSION: Preliminary clinical results are encouraging in terms of statistically significant improvements in VF, mfERG values, and MP. The subtenon injection of aPRP seems to be a therapeutic option for treatment and might lead to positive results in the vision of RPpatients. Long-term results regarding adverse events are unknown. There have not been any serious adverse events and any ophthalmic or systemic side effects for 1 year follow-up. Further studies with long-term follow-up are needed to determine the duration of efficacy and the frequency of application.
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