Clinical trial NCT04403750: Combined Laser-surgical Technology of RRD Treatment
Official title: Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Lead sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor class: OTHER_GOV
First posted: 2020-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.
2. Superior retinal break from 9 o'clock to 3 o'clock
3. Single retinal break not greater than 1 clock hours in size
4. Physically and mentally co-operated in post-operative head positioning
5. No (or minimal) proliferative vitreoretinopathy
6. None or mild vitreous hemorrhage.

Exclusion Criteria:

1. Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
2. Ocular media opacities
3. Previous ocular surgeries
4. Age \<18 years
5. Previous retinal detachment (index eye)

Primary outcomes:
measure: Retinal reattachment rate
timeFrame: in 1 month after gas resorption
Secondary outcomes:
measure: Anatomical success
timeFrame: 3, 6, 12 and 24 months post intervention
measure: Visual acuity
timeFrame: 3, 6, 12 and 24 months post intervention
measure: Visual acuity
timeFrame: 3, 6, 12 and 24 months post intervention
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The S.N. Fyodorov Eye Microsurgery State Institution.
Study officials:
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
name: Leonid Kryl, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
name: Mariiam Taevere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
name: Alexander Doga, Professor
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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