GaslEss Macular Hole Surgery

NCT06079593 | Not Yet Recruiting DMC

• 1 other identifier: 204994
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Macular holes are a hole in the centre of the retina, the light-sensing layer in the back of the eye. They cause a central 'blind spot' in the vision, which can be very disabling for patients. Standard surgery involves injecting a large gas bubble inside the eye. This takes 4-8 weeks to leave the eye. During this time vision is greatly reduced in the eye. This limits patients' ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract). The gas can also raise pressure inside the eye, causing pain and sometimes loss of vision. Patients cannot fly or have certain medicines until the gas absorbs. Critically, most patients position face down for 50 minutes out of every hour for a week after surgery. This is to float the gas bubble onto the macula. Head positioning is particularly difficult. It very often causes pain in the neck, back, arms and legs. Rarely, blood clots can form in the legs and be life-threatening if they dislodge and travel to the lungs. Head positioning also places a large burden on those caring for the patient. The gases are 'greenhouse' gases and cause damage to the environment, for about 3,200 years. This study looks at a new surgical technique for treating macular holes. The new technique aims to make patients' recovery from surgery easier, and safer. The purpose of this study therefore is to compare two treatments:

• Standard macular hole surgery with gas tamponade
• Novel macular hole surgery without tamponade Gathering feasibility data to inform a future fully powered trial

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (4)

• Feasibility: Screen failure

  Proportion of those screened who are randomised

  36 months

• Feasibility: Recruitment rate

  Recruitment rate (participants per site per month)

  36 months

• Feasibility: Participant retention

  Proportion reaching month 6 milestone visit

  6 months

• Feasibility: Cross-over

  Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks

  36 months

Secondary Outcomes (9)

• Efficacy Outcomes: Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)

  6 months

• Efficacy Outcomes: Surgical success

  3 months

• Efficacy Outcomes: Area under the BCVA versus time curve (ETDRS letter score)

  6 months

• Safety outcomes: Adverse events

  6 months

• Safety outcomes: Intra- and post-operative complications

  6 months

Study Arms (2)

Gasless Surgery

EXPERIMENTAL

Procedure: Gasless Macular hole surgery

Standard surgery with gas tamponade

ACTIVE COMPARATOR

Procedure: Standard Macular hole surgery

Interventions

Gasless Macular hole surgery PROCEDURE

Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering

Gasless Surgery

Standard Macular hole surgery PROCEDURE

Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane peel, and C2F6 tamponade

Standard surgery with gas tamponade

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requiring PPV to treat idiopathic (primary) FTMH.
• years or older
• ETDRS BCVA letter score of 1 or better in the study eye
• Able to provide written informed consent

You may not qualify if:

• General:
• Hypersensitivity to hyaluronate or other components of Healon Pro® viscoelastic
• Any major illness or major surgical procedure within 4 weeks
• Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol
• Study eye
• Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis
• Presence of fibrotic retinal proliferation or central epiretinal membrane (within 1 disc diameter of the fovea)
• Aphakia
• Current or former myopia greater than 6 dioptres
• Current or previous posterior uveitis or choroiditis
• Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to impair BCVA postoperatively or affect FTMH closure
• Current ocular or periocular infection, other than mild or moderate blepharitis
• Lens or media opacity that preclude adequate retinal assessment and imaging

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (1)

• Murphy GSP, Wafa HA, Tarpey M, Wyatt D, Wang Y, Steel DH, Jackson TL. Gas versus GaslEss surgery for full thickness Macular hole (GEM): study protocol for a randomised, assessor-masked, surgical feasibility study. BMJ Open Ophthalmol. 2025 Dec 25;10(1):e002260. doi: 10.1136/bmjophth-2025-002260.

  PMID: 41448786 DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Timothy Jackson, PhD, FRCOphth

  King's College London & King's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Murphy, MB BCh BAO, FRCOphth

CONTACT

(+)44 2032991297 ext 31297; george.murphy4@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Images will be graded in a masked fashion
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12