Air Tamponade Versus Fluorinated Gas Tamponade for Rhegmatogenous Retinal Detachment

NCT07034469 | Not Yet Recruiting DMC

• 1 other identifier: LHS0250
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

TITLE: RCT of air tamponade versus fluorinated gas tamponade for rhegmatogenous retinal detachment DESIGN: Non-inferiority RCT of 150 patients from 10 UK centres AIMS: To assess whether air tamponade is non inferior to gas tamponade for the repair of RRD treated with vitrectomy. PRIMARY OUTCOME MEASURE: Primary anatomical success with single operation at 24 weeks.

Conditions

Retinal Detachment Rhegmatogenous

Keywords

retinal detachment; gas tamponade; air

Outcome Measures

Primary Outcomes (1)

• Primary anatomical success

  Primary anatomical success at 24 weeks assessed by clinical examination by a retinal surgeon. The Outcome is binary with either 'successful retinal reattachement' or 'failed surgery'

  6 months

Secondary Outcomes (4)

• Post op visual acuity

  10 days, 6 weeks and 24 weeks

• Intraocular pressure

  Day 1, 10 and 6 and 24 weeks

• Quality of Life measures

  10 days, 6 and 24 weeks

• Patient Satisfaction

  10 days, 6 and 24 weeks

Study Arms (2)

Sterile air tamponade

EXPERIMENTAL

use of sterile air in place of fluorinated gases as a tamponade agent for rhegmatogenous retinal detachment vitrectomy surgery

Procedure: air

Fluorinated gas tamponade

ACTIVE COMPARATOR

use of fluorinated gas (SF6, C2F6 or C3F8) as a tamponade agent for rhegmatogenous retinal detachment treated with vitrectomy

Procedure: Gas SF6 (Sulfur Hexafluoride) and others

Interventions

air PROCEDURE

use of sterile air as a tamponade

Sterile air tamponade

Gas SF6 (Sulfur Hexafluoride) and others PROCEDURE

use of fluorinated gases such as SF6, C2F6 or C3F8 as a tamponade agent

Fluorinated gas tamponade

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary uncomplicated RRD undergoing vitrectomy.
• Phakic and pseudophakic eyes
• Retinal breaks superiorly between 3 and 9 o'clock, and that are separated by less than 4 clock hours.

You may not qualify if:

• Absence of PVD
• Age 40 years or younger
• PVR grade C or above
• Aphakia or anterior chamber lens
• Retinal breaks greater than 1 clock hour in size
• Retinal breaks that exist below 3 and 9 o'clock on both the nasal and temporal sides.
• Retinal breaks at or posterior to the vessel arcades
• Current or previous -6D myopia or greater (or axial length \>26millimetres (mm))
• Chronic RRD judged by the presence of subretinal bands and other signs of -chronicity or by history of visual loss for \>28 days.
• Significant inflammation, choroidal detachments, hypotony (\<6 millimetres of mercury (mmHg) preop)
• Previous open-globe injury, or endophthalmitis
• Current or previous posterior uveitis or choroiditis
• Any intraocular surgical procedure within 4 weeks other than laser/cryotherapy
• Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

MeSH Terms

Conditions

Retinal Detachment

Interventions

Air; Sulfur Hexafluoride

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Study Officials

• Rumana N Hussain, MBBS, FRCOph

  Liverpool University Hospitals NHS Foundation Trust UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rumana N Hussain, MBBS, FRCOph

CONTACT

01517063986; rumana.hussain@liverpoolft.nhs.uk

Darina Koneva

CONTACT

darina.koneva@liverpoolft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: one arm will have standard of care gas tamponade, the study arm will have air tamponade

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: June 24, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 20, 2029
• Study Completion (Estimated): March 20, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share