Combined Laser-surgical Technology of RRD Treatment

The S.N. Fyodorov Eye Microsurgery State Institution

Status: Unknown

Conditions: Rhegmatogenous Retinal Detachment

Treatments: Procedure: Combined laser-surgical technology of RRD treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04403750

Technology of RRD treatment

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Combined laser-surgical technology

Experimental group

Description:

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.

Treatment:

Procedure: Combined laser-surgical technology of RRD treatment