Full thickness macular hole and Internal Limiting Membrane (ILM) peeling Study: a randomised comparison of macular hole surgery with or without internal limiting membrane peeling
| ISRCTN | ISRCTN33175422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33175422 |
| ClinicalTrials.gov number | NCT00286507 |
| Secondary identifying numbers | HS028 RGC1462 |
- Submission date
- 02/08/2005
- Registration date
- 21/09/2005
- Last edited
- 17/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Noemi Lois
Scientific
Scientific
Eye Clinic, Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
| Phone | +44 (0)1224 553217 |
|---|---|
| noemilois@aol.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: https://medserv.abdn.ac.uk/films/documents/pdf/patientInformationSmPdf.pdf |
| Scientific title | Full thickness macular hole and Internal Limiting Membrane (ILM) peeling Study: a randomised comparison of macular hole surgery with or without internal limiting membrane peeling |
| Study acronym | FILMS |
| Study objectives | The principal research question is whether peeling the internal limiting membrane of the retina improves the vision of patients undergoing macular hole surgery. Secondary questions are whether peeling the internal limiting membrane of the retina improves the anatomical outcome of macular hole surgery and, subsequently, the quality of life of patients with macular holes. Whether internal limiting membrane peeling is cost-effective will also be considered. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Full-thickness macular holes in the centre of the retina |
| Intervention | Participants will undergo one of the two possible macular hole surgeries: 1. Surgery without ILM peeling 2. Surgery with ILM peeling |
| Intervention type | Other |
| Primary outcome measure | Distance visual acuity at 6 months post surgery. |
| Secondary outcome measures | Distance visual acuity at 3 months, near visual acuity at 3 and 6 months, contrast sensitivity at 6 months, reading speed at 6 months, health related quality of life, costs to the health service and the participant, incremental costs per QALY and adverse events. |
| Overall study start date | 01/06/2005 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Patients with idiopathic full-thickness macular holes (FTMHs) stages 2-3 of equal to or less than 18 months duration and with vision equal to or worse than 20/40 in the study eye. |
| Key exclusion criteria | Patients with macular holes of stage 1 or 4 or with a hole of greater than 18 months duration will be excluded. If the FTMH is related to high myopia or trauma or there are other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) will also be excluded. Patients who are unable to understand English or give informed consent to be excluded. |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Eye Clinic, Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
Kings College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Chief Scientist Office, Health Department, Scottish Executive (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/11/2008 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No |
Editorial Notes
17/08/2018: Publication reference added.
