Macular holes Eye Diseases Macular holes
Conditions
Interventions
Only patients who have been placed on the waiting list for primary macular hole surgery will be approached. The study will be explained to them and if they are eligible and agree to participate, they
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary idiopathic macular hole of any size and less than 12-month duration 2. Other previous treatments (gas, OCP) allowed 3. Full comprehension of study requirements at time of consent (at discretion of clinician) 4. Aged 50 years or older
Exclusion criteria
Exclusion criteria: 1. ILM peeling not planned 2. MH secondary to other causes including trauma, previous retinal detachment 3. Previous vitrectomy surgery 4. Previous significant macular disease affecting visual acuity (mild early or intermediate AMD allowed) 5. Advanced glaucoma 6. Known vision affecting optic nerve disease 7. Diabetic retinopathy of more than R1 including previously treated PDR 8. Significant intraocular inflammation 9. Myopia > -6 dioptres or axial length > 26mm 10. Amblyopia of less than ~6/18 11. Conditions affecting ability to perform visual fields or imaging 12. Participation in any other clinical/interventional trial that may impact study findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment and retention rate recorded as the number of eligible participants who consent to participate in the study over a four-month recruitment period and complete patient schedule in adherence to protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Inner retinal changes measured by standard visual acuity assessments, eye imaging and recording of any adverse events post-surgery at 3 weeks, 3 month and 6-month time points 2. Surgeon perception of device performance during ILM procedure measured by the study questionnaire completed immediately after surgery | — |
Countries
England, United Kingdom
Outcome results
None listed