GaslEss Macular Hole Surgery

ConditionMacular Holes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKing's College Hospital NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gasless Macular hole surgery

    Procedure/Surgery

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

  • Standard Macular hole surgery

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Gasless SurgeryExperimental treatment 1 intervention
Group B: Standard surgery with gas tamponadeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Screen failure

Proportion of those screened who are randomised

Time frame
36 months
2

Feasibility: Recruitment rate

Recruitment rate (participants per site per month)

Time frame
36 months
3

Feasibility: Participant retention

Proportion reaching month 6 milestone visit

Time frame
6 months
4

Feasibility: Cross-over

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

Time frame
36 months

Secondary outcomes

1

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

Mean change from baseline

Time frame
6 months
2

Efficacy Outcomes: Surgical success

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

Time frame
3 months
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator

This trial is not recruiting at the moment. You can still explore other options: