Comparison of Anatomical and Functional Outcomes of Laser Photocoagulation and Cryopexy in Patients with Rhegmatogenous Retinal Detachment Treated with Pneumatic Retinopexy

NCT06694259 | Recruiting

• 1 other identifier: 2181-147/01/06/LJ.Z.-23-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Rhegmatogenous Retinal Detachment is a pathological condition in which the inner layers of the retina separate from its outermost layer due to fluid entering between these layers through a retinal tear. Retinal detachment is one of the most urgent conditions in ophthalmology; if left untreated, it leads to severe vision loss and blindness. The only possible treatment is a surgical procedure to close the tear and reattach the separated retinal layers. Currently, three techniques are used for surgically managing retinal detachment with a tear. You will undergo a technique called pneumatic retinopexy. In this procedure, reattachment of the retina is achieved by injecting sulfur hexafluoride gas (SF6) into the vitreous (the gel that fills the eye) about 4 millimeters from the corneal edge, using a very fine needle. The retinal tear is then closed by either freezing (cryotherapy) immediately before the gas injection or by laser photocoagulation after the gas is introduced. The procedure will be done under local anesthesia, with the pupil first dilated using eye drops. After the procedure, a combination of antibiotics and corticosteroids will be instilled in the eye, followed by an ointment of the same combination, and the eye will be covered with a sterile dressing. You will need to maintain a specific head position, depending on the location of the retinal tear, for several days while the gas is present in the eye. This position helps the gas press against the tear, allowing it to heal. During this time, you should keep your head elevated, even at night, almost in a sitting position. Since the gas is lighter than the vitreous and rises within the eye, your head position should keep the tear positioned at 12 o'clock so the gas bubble can mechanically close it. Proper patient selection is essential for this procedure: only patients with retinal tears limited to the upper half of the retina, with one or more tears within an hour area of the peripheral retina, are suitable for this technique. The gas does not need to be removed, as it will spontaneously reabsorb over 6-7 days. While it is in your eye, you will see it as a single bubble that will gradually shrink over 6-7 days before disappearing. If you experience severe pain on the first day, notify your surgeon, as gas expansion within the eye could cause a temporary rise in eye pressure in the first 24-48 hours. You will need to remain in the same head position at home while the gas is present in your eye. While the gas is in place, you must not fly, as cabin pressure changes could cause the gas to expand. If you are unable to maintain the necessary position, this procedure may not be suitable for you, and an alternative technique would be needed. This technique is less invasive than the two other surgical treatments for retinal detachment. It is performed under local anesthesia, is brief, carries fewer risks, and does not require additional follow-up procedures if the surgery is successful, which largely depends on your adherence to postoperative care.

Conditions

Rhegmatogenous Retinal Detachment

Keywords

Rhegmatogenous retinal detachment; Pneumatic retinopexy; Transscleral cryopexy; Laser photocoagulation

Outcome Measures

Primary Outcomes (2)

• The percentage of patients who achieved primary retinal reattachment after undergoing pneumatic retinopexy during the 6-month follow-up period

  From enrollment to the end of the 6-month follow-up period

• The percentage of visual acuity improvement 6 months after the surgical procedure, assessed using the Snellen chart

  From enrollment to the end of the 6-month follow-up period

Study Arms (2)

Pneumatic retinopexy with transscleral cryopexy

ACTIVE COMPARATOR

Procedure: Pneumatic retinopexy with transscleral cryopexy

Pneumatic retinopexy with laser photocoagulation

ACTIVE COMPARATOR

Procedure: Pneumatic retinopexy with laser photocoagulation

Interventions

Pneumatic retinopexy with transscleral cryopexy PROCEDURE

Pneumatic retinopexy with transscleral cryopexy is a procedure used to treat certain types of rhegmatogenous retinal detachments. Procedure steps: Transscleral cryopexy: in this first step, the surgeon uses a cryoprobe applied to the sclera directly over the retinal tear. The cryoprobe emits extreme cold, creating a small, localized freeze that reaches the retina and seals the tear by causing a controlled scar to form. This scar tissue holds the retina in place and prevents further fluid from passing through the tear. Gas bubble injection: after the cryopexy, a small gas bubble (usually sulfur hexafluoride (SF6) or perfluoropropane (C3F8)) is injected into the vitreous cavity. This bubble applies upward pressure on the retina, gently pressing it against the back wall of the eye, which aids in reattaching the retina. Head positioning: for several days following the procedure, the patient must keep their head in a specific position so the gas bubble remains aligned with the retinal tear.

Pneumatic retinopexy with transscleral cryopexy

Pneumatic retinopexy with laser photocoagulation PROCEDURE

Pneumatic retinopexy with laser photocoagulation is a minimally invasive procedure used to repair certain types of rhegmatogenous retinal detachments. Procedure steps: Gas bubble injection: a small gas bubble, usually sulfur hexafluoride (SF6) or perfluoropropane (C3F8), is injected into the vitreous cavity which rises and applies pressure to the detached retina, pressing it back against the eye wall and helping to reapproximate the retinal layers. Laser photocoagulation: once the retina is positioned correctly, laser is used to create small burns around the retinal tear. This laser application causes a mild inflammatory response, creating a scar around the tear and effectively "welding" the retina to the underlying tissue. This seal prevents fluid from reaccumulating beneath the retina. Head positioning: following the procedure, the patient must keep their head in a specific position for several days. This positioning ensures that the gas bubble stays aligned with the retinal tear.

Pneumatic retinopexy with laser photocoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rhegmatogenous retinal detachment with one or more tears within two clock hours, limited to the upper half of the retina

You may not qualify if:

• Patients with 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 due to other conditions that could obstruct a detailed fundus examination or the procedure itself
• Patients unable to follow postoperative head positioning instructions
• Patients under age of 18 years

Sponsors & Collaborators

• Clinical Hospital Center, Split: lead

Study Sites (1)

Clinical Hospital Center, Split

Split, 21000, Croatia

RECRUITING

Study Officials

• Ivan Borjan, MD

  Clinical Hospital Center, Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Borjan, MD

CONTACT

+385981715350; ivan.borjan@kbsplit.hr

Ljubo Znaor, prof.

CONTACT

lznaor@kbsplit.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: December 18, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-11

Locations

CR (1)