Combined Laser-surgical Technology of RRD Treatment

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403750
• Other study ID #: Technology of RRD treatment
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: The S.N. Fyodorov Eye Microsurgery State Institution
• Contact: Mariiam Taevere, MD
• Phone: +79160173038
• Email: taeveremr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

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)

Locations

Country	Name	City	State
Russian Federation	The S.N. Fyodorov Eye Microsurgery State Institution.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution

Country where clinical trial is conducted

Russian Federation, 

References & 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal reattachment rate	complete retinal re-attachment	in 1 month after gas resorption
Secondary	Anatomical success	complete retinal re-attachment	3, 6, 12 and 24 months post intervention
Secondary	Visual acuity	ETDRS	3, 6, 12 and 24 months post intervention
Secondary	Visual acuity	Snellen	3, 6, 12 and 24 months post intervention

External 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