Combined Laser-surgical Technology of RRD Treatment

Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment

Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment

Study Overview

• Status: Unknown
• Conditions: Rhegmatogenous Retinal Detachment
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • The S.N. Fyodorov Eye Microsurgery State Institution.
    • Contact: Mariiam Taevere; Phone Number: +79160173038
    • Principal Investigator: Leonid Kryl, PhD, MD
    • Sub-Investigator: Mariiam Taevere, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combined laser-surgical technology; Combined laser-surgical technology includes 3 steps: Nd-YAG laser excision of the vitreoretinal traction zone; Pneumatic retinopexy (10% C3F8); Barrier laser photocoagulation around retinal break after retinal attachment.	Procedure: Combined laser-surgical technology of RRD treatment; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal reattachment rate	complete retinal re-attachment	in 1 month after gas resorption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical success	complete retinal re-attachment	3, 6, 12 and 24 months post intervention
Visual acuity	ETDRS	3, 6, 12 and 24 months post intervention
Visual acuity	Snellen	3, 6, 12 and 24 months post intervention

Collaborators and Investigators

• Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
• Investigators: Principal Investigator: Leonid Kryl, PhD, MD, S.N. Fyodorov Eye Microsurgery State Institution.; Principal Investigator: Mariiam Taevere, MD, S.N. Fyodorov Eye Microsurgery State Institution.; Study Director: Alexander Doga, Professor, S.N. Fyodorov Eye Microsurgery State Institution.

Publications and helpful links

General 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

Helpful Links

• Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography
• The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2018
• Primary Completion (ANTICIPATED): June 25, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment
• Other Study ID Numbers: Technology of RRD treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No