Actively Recruiting
Comparison of Anatomical and Functional Outcomes of Laser Photocoagulation and Cryopexy in Patients with Rhegmatogenous Retinal Detachment Treated with Pneumatic Retinopexy: a Randomized Clinical Trial
Led by Clinical Hospital Center, Split · Updated on 2024-12-19
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rhegmatogenous Retinal Detachment is a serious eye condition where the inner layers of the retina separate from the outer layer due to fluid entering through a tear. If untreated, it can cause severe vision loss and blindness. This research evaluates two surgical techniques, laser photocoagulation and cryopexy, used alongside pneumatic retinopexy to repair retinal detachment in patients with specific tear locations in the upper half of the retina. The study involves 40 patients who will receive pneumatic retinopexy, a procedure injecting sulfur hexafluoride gas (SF6) into the eye to press the retina back into place. Participants are randomly assigned to either receive transscleral cryopexy, which freezes the tear area to seal it, or laser photocoagulation, which uses laser burns to create a scar around the tear. Both techniques are performed under local anesthesia, and a small amount of eye fluid is withdrawn before gas injection to reduce pressure. Patients must maintain specific head positions post-surgery to ensure the gas bubble aligns with the tear. During the study, participants will be closely monitored with clinical exams to assess retinal reattachment and visual acuity improvements using the Snellen chart over six months. Postoperative care includes antibiotics and corticosteroids in the eye, head positioning guidance, and regular follow-up visits at the retinal disease clinic. Researchers will track safety, treatment outcomes, and adherence to postoperative instructions throughout the study period.
CONDITIONS
Brief Title
Comparison of Anatomical and Functional Outcomes of Laser Photocoagulation and Cryopexy in Patients with Rhegmatogenous Retinal Detachment Treated with Pneumatic Retinopexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with rhegmatogenous retinal detachment with one or more tears within two clock hours
- Retinal tears limited to the upper half of the retina
- Age 18 years or older
You will not qualify if you...
- Patients with retinal tears in the lower half of the retina
- Patients with multiple retinal tears covering more than two clock hours
- Patients with developed proliferative vitreoretinopathy
- Patients with vitreous hemorrhage
- Patients with opaque optical media obstructing detailed fundus examination or procedure
- Patients unable to follow postoperative head positioning instructions
- Patients under 18 years of age
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 - Surgery day plus 5 to 8 days post-surgery
Participants undergo pneumatic retinopexy surgery with either transscleral cryopexy or laser photocoagulation to repair retinal detachments. This includes gas injection in the eye and specific head positioning for several days to support healing.
1 surgical visit and daily head positioning for 5 to 8 days
Duration - 6 months
Participants are followed in the retinal disease clinic to monitor retinal reattachment and visual acuity improvement over a 6-month period after surgery.
Multiple postoperative clinic visits over 6 months
Trial Site Locations
Total: 1 location
1
Clinical Hospital Center, Split
Split, Croatia, 21000
Actively Recruiting
Research Team
I
Ivan Borjan, MD
L
Ljubo Znaor, prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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