Actively Recruiting
A Prospective Study Assessing the Impact of Tixel Treatment of Peri Orbital Wrinkles on Symptoms and Signs in Patients With Dry Eye Disease
Led by Aston University · Updated on 2026-01-26
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a standard Tixel treatment compares to a sham treatment for reducing eye wrinkles and improving symptoms and signs of Dry Eye Disease (DED). This prospective study aims to assess the safety and effects of these treatments on patients with mild to moderate peri-orbital wrinkles and DED symptoms. Participants will be randomly assigned to receive either three Tixel treatments or three sham treatments, each spaced two weeks apart. The Tixel treatment involves thermo-mechanical action targeting the skin around the eyes to potentially improve wrinkle appearance and dry eye symptoms. The study includes a single-blind design where participants do not know which treatment they receive. During the study, participants will be monitored for adverse events to evaluate safety, and researchers will assess changes in dry eye symptoms and signs over an average of four months. Participants must attend all study visits and follow instructions, with assessments including symptom questionnaires and clinical measurements of eye surface stability. The total participation duration includes these treatment and follow-up periods.
CONDITIONS
Brief Title
Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mild to moderate peri-orbital wrinkles
- OSDI score of at least 23
- Noninvasive tear film break up time (NIBUT) of 10 seconds or less
- No other eye, skin, or immune problems
- Willing and able to provide written informed consent
- Willing to participate in all study activities and follow instructions
You will not qualify if you...
- Pregnancy or breastfeeding
- Lesions in the peri-orbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Use of eye drops within 2 hours before examination
- Other anterior eye diseases
- Recent outdoor or sunbed tanning within last 4 weeks
- Unwillingness to follow Tixel aftercare instructions
- Active or history of Herpes Simplex in the peri-orbital area
- Current skin cancer or advanced premalignant lesions in treatment area
- Impaired immune system or use of immunosuppressive medication
- Collagen disorders, keloid formation, or abnormal wound healing
- Recent invasive or ablative procedures in treatment areas within 3 months
- Use of medications, herbal treatments, supplements, or vitamins affecting skin healing within last 3 months
- Oral Isotretinoin use within 3 months prior to treatment
- History of bleeding disorders or use of anticoagulants
- Tattoos or permanent makeup in treatment area
- Burned, blistered, irritated, or sensitive skin in treatment area
- Thread lifting of treatment area within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive three Tixel or sham treatments at 2-week intervals to assess impact on dry eye disease symptoms and signs.
3 treatment visits scheduled 2 weeks apart
Duration - Up to 4 months after treatment
Participants are monitored for safety and treatment effects through study completion.
Periodic visits during follow-up up to 4 months
Trial Site Locations
Total: 1 location
1
Vision Science, School of Optometry
Birmingham, United Kingdom, B4 7ET
Actively Recruiting
Research Team
S
Sunil Shah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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