Rhegmatogenous Retinal DetachmentNCT04403750
Combined Laser-surgical Technology of RRD Treatment
A study testing Combined laser-surgical technology of RRD treatment in people with Rhegmatogenous Retinal Detachment, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
Trial summary
Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Combined laser-surgical technology of RRD treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.
- Superior retinal break from 9 o'clock to 3 o'clock
- Single retinal break not greater than 1 clock hours in size
- Physically and mentally co-operated in post-operative head positioning
- No (or minimal) proliferative vitreoretinopathy
- None or mild vitreous hemorrhage.
Who cannot join
- Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- Ocular media opacities
- Previous ocular surgeries
- Age <18 years
- Previous retinal detachment (index eye)
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
The S.N. Fyodorov Eye Microsurgery State Institution.
Moscow
Mariiam Taevere, +79160173038
Leonid Kryl, PhD, MD
About this study
Official title: Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment
Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment
Read the detailed description
The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.
The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.
The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Combined laser-surgical technology of RRD treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined laser-surgical technology of RRD treatmentProcedure or surgery
- Nd-YAG laser excision of the vitreoretinal traction zone
- Pneumatic retinopexy (10% C3F8)
- barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)
| Study group | Role | What they receive |
|---|---|---|
| Combined laser-surgical technology | Experimental | Combined laser-surgical technology includes 3 steps:
1. Nd-YAG laser excision of the vitreoretinal traction zone
2. Pneumatic retinopexy (10% C3F8)
3. Barrier laser photocoagulation around retinal break after retinal attachment. Receives: Procedure: Combined laser-surgical technology of RRD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rate
complete retinal re-attachment
Measured: in 1 month after gas resorption
Secondary outcomes (3)
Anatomical success
complete retinal re-attachment
Measured: 3, 6, 12 and 24 months post intervention
Visual acuity
ETDRS
Measured: 3, 6, 12 and 24 months post intervention
Visual acuity
Snellen
Measured: 3, 6, 12 and 24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start15 Sep 2018
- Primary completion25 Jun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taevere M.R, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Leonid Kryl, PhD, MD, Principal investigator, S.N. Fyodorov Eye Microsurgery State Institution.Mariiam Taevere, MD, Principal investigator, S.N. Fyodorov Eye Microsurgery State Institution.Alexander Doga, Professor, Study director, S.N. Fyodorov Eye Microsurgery State Institution.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403750
- Sponsor's protocol ID
- Technology of RRD treatment
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayzulaeva M.R., Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A. [Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography]. Modern technologies in ophtalmology. 2019 June 25. doi: https://doi.org/10.25276/2312-4911-2019-4-20-23
Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A., Bayzulaeva M.R. [The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment]. Modern technologies in ophtalmology. 2019 March 20. doi: https://doi.org/10.25276/2312-4911-2019-1-363-368
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment
- ClinicalTrials.gov ID
- NCT04403750
- Acronym / sponsor ID
- Technology of RRD treatment
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 25 Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 27 May 2020 (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.
Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment
Detailed description
The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.
The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.
The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined laser-surgical technology | Experimental | Procedure: Combined laser-surgical technology of RRD treatmentCombined laser-surgical technology includes 3 steps: 1. Nd-YAG laser excision of the vitreoretinal traction zone 2. Pneumatic retinopexy (10% C3F8) 3. Barrier laser photocoagulation around retinal break after retinal attachment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.
- Superior retinal break from 9 o'clock to 3 o'clock
- Single retinal break not greater than 1 clock hours in size
- Physically and mentally co-operated in post-operative head positioning
- No (or minimal) proliferative vitreoretinopathy
Key exclusion criteria (5 listed)
- Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- Ocular media opacities
- Previous ocular surgeries
- Age <18 years
- Previous retinal detachment (index eye)
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 |
|---|---|---|
| Combined laser-surgical technology of RRD treatment1. Nd-YAG laser excision of the vitreoretinal traction zone 2. Pneumatic retinopexy (10% C3F8) 3. barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy) | Procedure or surgery | Combined laser-surgical technology |
Primary outcome
Retinal reattachment rate
Time frame: in 1 month after gas resorption
complete retinal re-attachment
3 secondary outcomes
Anatomical success
Time frame: 3, 6, 12 and 24 months post intervention
Visual acuity
Time frame: 3, 6, 12 and 24 months post intervention
Visual acuity
Time frame: 3, 6, 12 and 24 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- BackgroundBayzulaeva M.R., Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A. [Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography]. Modern technologies in ophtalmology. 2019 June 25. doi: https://doi.org/10.25276/2312-4911-2019-4-20-23
- BackgroundDoga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A., Bayzulaeva M.R. [The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment]. Modern technologies in ophtalmology. 2019 March 20. doi: https://doi.org/10.25276/2312-4911-2019-1-363-368
- Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomographyLink provided by the sponsor.
- The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Rhegmatogenous Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Not yet recruitingPhase 1
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy
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. This study is not recruiting at the moment.
Leonid Kryl, PhD, MD principal investigator
S.N. Fyodorov Eye Microsurgery State Institution.
Mariiam Taevere, MD principal investigator
S.N. Fyodorov Eye Microsurgery State Institution.
Alexander Doga, Professor study director
S.N. Fyodorov Eye Microsurgery State Institution.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined laser-surgical technology of RRD treatment in people with Rhegmatogenous Retinal Detachment, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariiam Taevere, MD (+79160173038, taeveremr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal reattachment rate (time frame: in 1 month after gas resorption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403750, which also lists 2 linked publications.
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 29 May 2020.