Retinitis Pigmentosa. Hereditary retinal dystrophy
Conditions
Interventions
Intervention 1: Intervention group: 1 sub-Tenon injection of Wharton's jelly stem cells. Intervention 2: Control group: Eye health status before 1 sub-Tenon injection of Wharton's jelly stem cells. In
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with retinal degenerative disease. Patients not currently enrolled in another clinical trial. Patients with no history of severe allergic reactions. Patients with adequate systemic health to undergo treatment. Patients with clear understanding and willingness to comply with study protocols. Patients with retinal degenerative disease that have not responded to conventional treatments.
Exclusion criteria
Exclusion criteria: History of severe allergic reactions to biological treatments. Presence of active or untreated infection. Current use of immunosuppressive therapy. Pregnant or breastfeeding women. Diagnosis of any other progressive or terminal illness. Significant uncontrolled systemic disease (e.g., cardiovascular, hepatic, or renal). Prior participation in a study with a similar intervention within the last 6 months. Any condition that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol or pose a risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity, visual field, Optical coherence tomography, brain map, satisfaction with treatment, and quality of life (standard questionnaire). Timepoint: Before the start of the intervention and at months 1, 6, and 12 after treatment. Method of measurement: The primary outcome variable of this study is corrected visual acuity. The standard Early Treatment Diabetic Retinopathy Study Chart (ETDRS) will be used to measure this variable at a distance of four meters and under controlled lighting conditions. Visual acuity will be measured in each eye after complete refraction and recorded numerically based on the logarithm of the Minimum Angle of Resolution. The change in visual acuity from baseline to the last visit will be the primary outcome of this study. Visual field: The Humphrey Field Analyzer with the standard program 24-2 will be used to measure visual field. The Mean Deviation Index is considered the main criterion for analysis. Optical Coherence Tomography: Evaluation of retinal thickness and structural changes will be performed using a Spectral Domain Optical Coherence Tomography (Spectral Domain Optical Coherence Tomography) device, Heidelberg Spectralis or Zeiss Cirrus model. Brain Mapping: Pattern Reversal Visual Evoked Potentials are used to examine cortical activities related to vision, in accordance with the International Society of Electrophysiology of Vision (ISCEV) standards. Latency and P100 amplitude indices will be analyzed. Treatment satisfaction: Participants' satisfaction with treatment will be assessed using a self-administered Client Satisfaction Questionnaire (Version 8). Quality of life: Vision-related quality of life will be measured using the National Eye Institute Visual Function Questionnaire (25 Item). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Sanie-Jahromi
Shiraz University of Medical Sciences
Outcome results
None listed