BACKGROUND:Retinitis pigmentosa (RP) therapy is still an unsolved challenge. Recent reports have underlined that hyperbaric oxygen (HBO) therapy could play a role in slowing the retinal degenerative process. The aim of this study was to assess the efficacy of HBO therapy on visual function in RP patients. METHODS: We performed a single-center, comparative, longitudinal case-controlled randomized clinical trial, which lasted 10 years. We randomly divided RP patients into two groups. Group 1, the control group, consisted of 44 RP patients (21 males and 23 females; mean age 35.5) who took Vitamin A. Group 2, with 44 RP patients (21 males and 23 females; mean age 35,02), underwentHBO therapy. No statistically significant difference was found at the beginning of the study between the two groups. We compared the results concerning visual acuity, Goldmann perimetry, static perimetry Humphrey field analyzer (HFA), and electroretinogram (ERG) obtained in the two groups at 5 and 10 years follow-up. Statistical analysis was performed with Kaplan-Meier life-table with the evaluation of log-rank coefficient. RESULTS: At 5 year follow-up, 87.5% of group 2 patients preserved 80% of the initial visual acuity, while the same result was achieved in only 70.4% of group 1 patients (X(2) = 8.2; p < 0.01); at 10 year follow-up, 63.33% of group 2 patients preserved 80% of the initial visual acuity, while the same percentage of residual visual acuity was maintained in 40% of group 1 patients (X(2) = 3.22; p = 0.05). At 10 year follow-up, Goldmann perimetry (target I4e) did not change in 31.6% of group 2 and in 10.5% of group 1; evaluation of mean defect (MD) with static perimetry HFA showed that 53% of HBO patients had 80% of residual mean sensitivity compared to 23.5% of the control group patients (X(2) = 4.72; p = 0.035). ERG b-wave mean values at the end of the protocol were significantly higher in the HBO treated group (X(2) = 4.53; p = 0.013). CONCLUSION: Our study underlines that HBO therapy can be a safe alternative approach to RP patients, contributing to the stabilization of their visual function concerning visual acuity, visual field, and ERG responses while waiting for a definite cure.
RCT Entities:
BACKGROUND:Retinitis pigmentosa (RP) therapy is still an unsolved challenge. Recent reports have underlined that hyperbaric oxygen (HBO) therapy could play a role in slowing the retinal degenerative process. The aim of this study was to assess the efficacy of HBO therapy on visual function in RP patients. METHODS: We performed a single-center, comparative, longitudinal case-controlled randomized clinical trial, which lasted 10 years. We randomly divided RP patients into two groups. Group 1, the control group, consisted of 44 RP patients (21 males and 23 females; mean age 35.5) who took Vitamin A. Group 2, with 44 RP patients (21 males and 23 females; mean age 35,02), underwent HBO therapy. No statistically significant difference was found at the beginning of the study between the two groups. We compared the results concerning visual acuity, Goldmann perimetry, static perimetry Humphrey field analyzer (HFA), and electroretinogram (ERG) obtained in the two groups at 5 and 10 years follow-up. Statistical analysis was performed with Kaplan-Meier life-table with the evaluation of log-rank coefficient. RESULTS: At 5 year follow-up, 87.5% of group 2 patients preserved 80% of the initial visual acuity, while the same result was achieved in only 70.4% of group 1 patients (X(2) = 8.2; p < 0.01); at 10 year follow-up, 63.33% of group 2 patients preserved 80% of the initial visual acuity, while the same percentage of residual visual acuity was maintained in 40% of group 1 patients (X(2) = 3.22; p = 0.05). At 10 year follow-up, Goldmann perimetry (target I4e) did not change in 31.6% of group 2 and in 10.5% of group 1; evaluation of mean defect (MD) with static perimetry HFA showed that 53% of HBO patients had 80% of residual mean sensitivity compared to 23.5% of the control group patients (X(2) = 4.72; p = 0.035). ERG b-wave mean values at the end of the protocol were significantly higher in the HBO treated group (X(2) = 4.53; p = 0.013). CONCLUSION: Our study underlines that HBO therapy can be a safe alternative approach to RP patients, contributing to the stabilization of their visual function concerning visual acuity, visual field, and ERG responses while waiting for a definite cure.