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Combined Laser-surgical Technology of RRD Treatment

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Combined laser-surgical technology of RRD treatment
Sponsored by
The S.N. Fyodorov Eye Microsurgery State Institution
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The S.N. Fyodorov Eye Microsurgery State Institution.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined laser-surgical technology

Arm Description

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.

Outcomes

Primary Outcome Measures

Retinal reattachment rate
complete retinal re-attachment

Secondary Outcome Measures

Anatomical success
complete retinal re-attachment
Visual acuity
ETDRS
Visual acuity
Snellen

Full Information

First Posted
May 21, 2020
Last Updated
May 27, 2020
Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
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1. Study Identification

Unique Protocol Identification Number
NCT04403750
Brief Title
Combined Laser-surgical Technology of RRD Treatment
Official Title
Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined laser-surgical technology
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Combined laser-surgical technology of RRD treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Retinal reattachment rate
Description
complete retinal re-attachment
Time Frame
in 1 month after gas resorption
Secondary Outcome Measure Information:
Title
Anatomical success
Description
complete retinal re-attachment
Time Frame
3, 6, 12 and 24 months post intervention
Title
Visual acuity
Description
ETDRS
Time Frame
3, 6, 12 and 24 months post intervention
Title
Visual acuity
Description
Snellen
Time Frame
3, 6, 12 and 24 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariiam Taevere, MD
Phone
+79160173038
Email
taeveremr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leonid Kryl, PhD, MD
Phone
+79163747142
Email
doctor-leonid@inbox.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Kryl, PhD, MD
Organizational Affiliation
S.N. Fyodorov Eye Microsurgery State Institution.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariiam Taevere, MD
Organizational Affiliation
S.N. Fyodorov Eye Microsurgery State Institution.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Doga, Professor
Organizational Affiliation
S.N. Fyodorov Eye Microsurgery State Institution.
Official's Role
Study Director
Facility Information:
Facility Name
The S.N. Fyodorov Eye Microsurgery State Institution.
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariiam Taevere
Phone
+79160173038
First Name & Middle Initial & Last Name & Degree
Leonid Kryl, PhD, MD
First Name & Middle Initial & Last Name & Degree
Mariiam Taevere, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
background
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
Results Reference
background
Links:
URL
https://eyepress.ru/article.aspx?40421
Description
Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography
URL
https://eyepress.ru/article.aspx?30058
Description
The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment

Learn more about this trial

Combined Laser-surgical Technology of RRD Treatment

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