Retinitis Pigmentosa
Conditions
Brief summary
This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.
Detailed description
The retinitis pigmentosa(RP) is an hereditary disease which causes visual deficiency leading to blindness. The methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. But all these methods own limitations can not be conquered in a short period. It was proved that vascular endothelial growth factor (VEGF) and pigment epithelium derived factor (PEDF) decreased in the aqueous humor of patients of RP. But the traditional exogenous nerve growth factors (NGFs) were immunogenic proteins and may cause inflammation. Autoserum contain a large amount of active factors and will not cause exclusive reaction. In this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.
Interventions
PROCEDUREretrobulbar injection of autoserum
Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, local autoserum is injected into the retrobulbar space for the neurotrophic purpose.
PROCEDUREretrobulbar injection of placebo
Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, normal saline (NS) is injected into the retrobulbar space as a comparison
Sponsors
Aier School of Ophthalmology, Central South University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Two eyes of one patient with RP will be divided into two groups. One eye with more serious retinal atrophy will receive retrobulbar injection of autoserum, and the other eye will receive retrobulbar injection of saline solution.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of retinitis pigmentosa
Exclusion criteria
* Suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease * Combined with serious systemic disease * Can not cooperate with the interventions and examinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the visual acuity | one day before injection, one day, one month, three months and six months after surgery | To measure the visual acuity with logarithmic visual chart. |
| Change of the contrast sensitivity | one day before injection, one month, three months and six months after surgery | To access the change of contrast sensitivity in different special frequency. |
| Change of the electrophysiological detection (flash electroretinogram) | one day before injection, three months and six months after surgery | To evaluate the retinal function with the use of flash electroretinogram (F-ERG). |
| Change of the electrophysiological detection (electro-oculogram) | one day before injection, three months and six months after surgery | To evaluate the retinal function with the use of electro-oculogram (EOG) |
Contacts
Primary ContactHongxia Wang, MD
Backup ContactWensheng Li, MD,PHD
Outcome results
None listed