Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-10-06
Brief Title:
GaslEss Macular Hole Surgery
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
GaslEss Macular Hole Surgery GEM a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
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 3200 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
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 3200 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None