GaslEss Macular Hole Surgery

NCT ID: NCT06079593

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-10-31

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

Detailed Description

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.

Conditions

Macular Holes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Gasless Surgery

Group Type: EXPERIMENTAL

Gasless Macular hole surgery

Intervention Type: PROCEDURE

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

Standard surgery with gas tamponade

Group Type: ACTIVE_COMPARATOR

Standard Macular hole surgery

Intervention Type: PROCEDURE

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

Interventions

Gasless Macular hole surgery

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

Intervention Type: PROCEDURE

Standard Macular hole surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Jackson, PhD, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

King's College London & King's College Hospital

Central Contacts

George Murphy, MB BCh BAO, FRCOphth

Role: CONTACT

Phone: (+)44 2032991297 ext 31297

Email: george.murphy4@nhs.net

Other Identifiers

204994

Identifier Type: -

Identifier Source: org_study_id