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Combined Laser-surgical Technology of RRD Treatment

Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04403750
Enrollment
50
Registered
2020-05-27
Start date
2018-09-15
Completion date
2021-06-30
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhegmatogenous Retinal Detachment

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.

Interventions

PROCEDURECombined laser-surgical technology of RRD treatment

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)

Sponsors

The S.N. Fyodorov Eye Microsurgery State Institution
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Retinal reattachment ratein 1 month after gas resorptioncomplete retinal re-attachment

Secondary

MeasureTime frameDescription
Anatomical success3, 6, 12 and 24 months post interventioncomplete retinal re-attachment
Visual acuity3, 6, 12 and 24 months post interventionETDRS

Countries

Russia

Contacts

Primary ContactMariiam Taevere, MD
taeveremr@gmail.com+79160173038
Backup ContactLeonid Kryl, PhD, MD
doctor-leonid@inbox.ru+79163747142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026