Rhegmatogenous Retinal DetachmentNCT06694259
Comparison of Anatomical and Functional Outcomes of Laser Photocoagulation and Cryopexy in Patients with Rhegmatogenous Retinal Detachment Treated with Pneumatic Retinopexy
A study testing Pneumatic retinopexy with transscleral cryopexy and Pneumatic retinopexy with laser photocoagulation in people with Rhegmatogenous Retinal Detachment, run by Clinical Hospital Center, Split at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Pneumatic retinopexy with transscleral cryopexy and Pneumatic retinopexy with laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 18 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rhegmatogenous retinal detachment with one or more tears within two clock hours, limited to the upper half of the retina
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ljubo Znaor, prof. contact
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Center, Split
Split, 21000
Ivan Borjan, MD, +385981715350, ivan.borjan@kbsplit.hr
Ljubo Znaor, prof., +385915052181, lznaor@kbsplit.hr
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This study will include 40 patients with rhegmatogenous retinal detachment with one or more retinal breaks within two clock hours, limited to the upper half of the retina, who will be treated with pneumatic retinopexy. The patients will be thoroughly informed about the surgical procedure and the risks of potential complications. After a detailed clinical examination and the selection of suitable patients for this surgical method, the chosen patients will be randomized into two groups.
In the first group, patients will undergo transscleral cryopexy at the site of the retinal break (retrobulbar anesthesia will be given), guided by indirect ophthalmoscopy, during the same procedure. In the second group, after retinal reattachment, laser photocoagulation will be performed.
Before insufflation of the gas in the vitreous cavity, paracentesis of the anterior chamber will be performed to prevent increased intraocular pressure (0.2 mL of fluid will be withdrawn from the anterior chamber, with a 30-gauge needle). In both groups, patients will receive sulfur hexafluoride gas (SF6) in the vitreous space (0.5 mL). The gas will be injected with a 30-gauge needle, 3.5 or 4 mm from the corneal limbus (depending on the lens status: phakic/pseudophakic), at a moderate pace to avoid the formation of numerous little bubbles - a "fish eggs" phenomenon. Afterwards, evaluation of IOP will be performed by carefully evaluation of the central retinal artery for perfusion and confirmation of the light perception.
All patients will receive postoperative topical therapy with a combination of antibiotics and corticosteroids, and their head positioning will be adjusted according to the location of the retinal break(s) (positioned opposite to the retinal break for 5-8 days post-surgery, for 16 hours a day). Patients will receive appropriate hospital care and will be followed up in the retinal disease clinic postoperatively.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Pneumatic retinopexy with transscleral cryopexy, Pneumatic retinopexy with laser photocoagulation
- Keywords
- Rhegmatogenous retinal detachment, Pneumatic retinopexy, Transscleral cryopexy, Laser photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic retinopexy with transscleral cryopexyProcedure or surgery
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 laser photocoagulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic retinopexy with transscleral cryopexy | Active comparator | Not described Receives: Procedure: Pneumatic retinopexy with transscleral cryopexy |
| Pneumatic retinopexy with laser photocoagulation | Active comparator | Not described Receives: Procedure: Pneumatic retinopexy with laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who achieved primary retinal reattachment after undergoing pneumatic retinopexy during the 6-month follow-up period
Measured: 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
Measured: From enrollment to the end of the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Dec 2024
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center, Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Borjan, Clinical Hospital Center, Split
- Investigators
- Ivan Borjan, MD, Principal investigator, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694259
- Sponsor's protocol ID
- 2181-147/01/06/LJ.Z.-23-02
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06694259
- Acronym / sponsor ID
- 2181-147/01/06/LJ.Z.-23-02
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Rhegmatogenous retinal detachment, Pneumatic retinopexy, Transscleral cryopexy, Laser photocoagulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinical Hospital Center, SplitUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will include 40 patients with rhegmatogenous retinal detachment with one or more retinal breaks within two clock hours, limited to the upper half of the retina, who will be treated with pneumatic retinopexy. The patients will be thoroughly informed about the surgical procedure and the risks of potential complications. After a detailed clinical examination and the selection of suitable patients for this surgical method, the chosen patients will be randomized into two groups.
In the first group, patients will undergo transscleral cryopexy at the site of the retinal break (retrobulbar anesthesia will be given), guided by indirect ophthalmoscopy, during the same procedure. In the second group, after retinal reattachment, laser photocoagulation will be performed.
Before insufflation of the gas in the vitreous cavity, paracentesis of the anterior chamber will be performed to prevent increased intraocular pressure (0.2 mL of fluid will be withdrawn from the anterior chamber, with a 30-gauge needle). In both groups, patients will receive sulfur hexafluoride gas (SF6) in the vitreous space (0.5 mL). The gas will be injected with a 30-gauge needle, 3.5 or 4 mm from the corneal limbus (depending on the lens status: phakic/pseudophakic), at a moderate pace to avoid the formation of numerous little bubbles - a "fish eggs" phenomenon. Afterwards, evaluation of IOP will be performed by carefully evaluation of the central retinal artery for perfusion and confirmation of the light perception.
All patients will receive postoperative topical therapy with a combination of antibiotics and corticosteroids, and their head positioning will be adjusted according to the location of the retinal break(s) (positioned opposite to the retinal break for 5-8 days post-surgery, for 16 hours a day). Patients will receive appropriate hospital care and will be followed up in the retinal disease clinic postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with rhegmatogenous retinal detachment with one or more tears within two clock hours, limited to the upper half of the retina
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic retinopexy with transscleral cryopexyPneumatic 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. | Procedure or surgery | Pneumatic retinopexy with transscleral cryopexy |
| Pneumatic retinopexy with laser photocoagulationPneumatic 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. | Procedure or surgery | Pneumatic retinopexy with laser photocoagulation |
Primary outcome
The percentage of patients who achieved primary retinal reattachment after undergoing pneumatic retinopexy during the 6-month follow-up period
Time frame: 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
Time frame: From enrollment to the end of the 6-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ljubo Znaor, prof. contact
Ivan Borjan, MD principal investigator
Clinical Hospital Center, Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic retinopexy with transscleral cryopexy and Pneumatic retinopexy with laser photocoagulation in people with Rhegmatogenous Retinal Detachment, run by Clinical Hospital Center, Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Borjan, MD (+385981715350, ivan.borjan@kbsplit.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieved primary retinal reattachment after undergoing pneumatic retinopexy during the 6-month follow-up period (time frame: From enrollment to the end of the 6-month follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.