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NCT Number: NCT06079593

GaslEss Macular Hole Surgery

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The investigators are testing a new surgical technique, that does not use the gas bubble and face down positioning. Instead, a licensed surgical gel and thin flap of retinal tissue seal the macular hole. Early small studies suggest the new technique is safe and works as well as standard surgery.

The investigators will invite 60 people with macular hole to take part in the study. Half will be randomly allocated to the new technique and half to standard surgery. All participants will return at regular intervals after surgery for review. The investigators will test their vision, examine their eyes, and ask participants to complete questionnaires about their treatment and vision.

The investigators aim to examine if the technique appears safe and works well at closing macular holes. It will also inform if a larger clinical trial is possible.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gasless Macular hole surgery

Procedure

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

Standard Macular hole surgery

Procedure

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

Primary outcomes

  1. Feasibility: Screen failure

    Time frame: 36 months

    Proportion of those screened who are randomised

  2. Feasibility: Recruitment rate

    Time frame: 36 months

    Recruitment rate (participants per site per month)

  3. Feasibility: Participant retention

    Time frame: 6 months

    Proportion reaching month 6 milestone visit

  4. Feasibility: Cross-over

    Time frame: 36 months

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

Secondary outcomes

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

    Time frame: 6 months

    Mean change from baseline

  2. Efficacy Outcomes: Surgical success

    Time frame: 3 months

    Proportion with FTMH closure within 3 months, without further FTMH surgery

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

    Time frame: 6 months

  4. Safety outcomes: Adverse events

    Time frame: 6 months

  5. Safety outcomes: Intra- and post-operative complications

    Time frame: 6 months

  6. Safety outcomes: Development or progression of lens opacity

    Time frame: 6 months

    Within 6 months of vitrectomy (proportion undergoing or listed for cataract surgery and mean change in Lens Opacities Classification System 2 [LOCS2] grading)

  7. Patient reported outcomes measures: Participant acceptability of the intervention

    Time frame: 6 months

    Assessed by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; composite score)

  8. Patient reported outcomes measures: National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ25; composite score)

    Time frame: 6 months

  9. Patient reported outcomes measures: Qualitative analysis

    Time frame: 6 months

    Analysis of participant feedback

Study contacts

Contact information is provided by the study sponsor or research team.

George Murphy, MB BCh BAO, FRCOphth

CONTACT

[email protected]

(+)44 2032991297 ext 31297

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

GaslEss Macular Hole Surgery (GEM): a Feasibility Study

Acronym: GEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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