NCT04403750

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

May 21, 2020

Last Update Submit

May 27, 2020

Conditions

Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Retinal reattachment rate

    complete retinal re-attachment

    in 1 month after gas resorption

Secondary Outcomes (3)

  • Anatomical success

    3, 6, 12 and 24 months post intervention

  • Visual acuity

    3, 6, 12 and 24 months post intervention

  • Visual acuity

    3, 6, 12 and 24 months post intervention

Study Arms (1)

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.

Procedure: Combined laser-surgical technology of RRD treatment

Interventions

Combined laser-surgical technology of RRD treatmentPROCEDURE

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 (2-3 days after pneumatic retinopexy)

Combined laser-surgical technology

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The S.N. Fyodorov Eye Microsurgery State Institution.

Moscow, Russia

RECRUITING

Related Publications (2)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

Related Links

Study Officials

  • Leonid Kryl, PhD, MD

    S.N. Fyodorov Eye Microsurgery State Institution.

    PRINCIPAL INVESTIGATOR

  • Mariiam Taevere, MD

    S.N. Fyodorov Eye Microsurgery State Institution.

    PRINCIPAL INVESTIGATOR

  • Alexander Doga, Professor

    S.N. Fyodorov Eye Microsurgery State Institution.

    STUDY DIRECTOR

Central Study Contacts

Mariiam Taevere, MD

CONTACT

+79160173038taeveremr@gmail.com

Leonid Kryl, PhD, MD

CONTACT

+79163747142doctor-leonid@inbox.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

September 15, 2018

Primary Completion

June 25, 2020

Study Completion

June 1, 2021

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)