Combined Laser-surgical Technology of RRD Treatment

Not Applicable

• Conditions: Rhegmatogenous Retinal Detachment

• Registration Number: NCT04403750
• Lead Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution

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.

Study Timeline

• Study Start: 2018-09-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29
• Primary Completion: 2020-06-25
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Retinal reattachment rate	in 1 month after gas resorption	complete retinal re-attachment

Secondary Outcome Measures

Name	Time	Method
Anatomical success	3, 6, 12 and 24 months post intervention	complete retinal re-attachment
Visual acuity	3, 6, 12 and 24 months post intervention	Snellen

Trial Locations

Locations (1)

The S.N. Fyodorov Eye Microsurgery State Institution.; 🇷🇺 Moscow, Russian Federation