Assessment of retinal function before and after idiopathic macular hole surgery
| ISRCTN | ISRCTN31177220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31177220 |
| Protocol serial number | N/A |
| Sponsor | Catholic University of Sacro Cuore (Italy) |
| Funder | Catholic University of Sacro Cuore (Italy) |
- Submission date
- 14/11/2012
- Registration date
- 27/11/2013
- Last edited
- 27/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Idiopathic macular hole (a small gap that opens up at the centre of the retina, in an area called the macula) causes central vision loss in the elderly. The aim of the study is to assess the effectiveness and safety of pars plana vitrectomy (a surgical procedure that involves removal of vitreous gel from the eye) and internal limiting membrane peeling assisted by intravitreal injection of triamcinolone acetonide or infracyanine green.
Who can participate?
Patients of any age and gender affected by full thickness idiopathic macular hole can participate.
What does the study involve?
Patients are randomly allocated to one of two groups. One group is treated with pars plana vitrectomy and internal limiting membrane peeling assisted by intravitreal injection of triamcinolone acetonide. The second group is treated with pars plana vitrectomy and internal limiting membrane peeling assisted by intravitreal injection of infracyanine green. Retinal function is assessed in patients of both groups before and after the operation.
What are the possible benefits and risks of participating?
The expected benefits of surgical treatment are the closure of the hole with improvement in vision. Possible risks related to the surgical procedure are eye infection, vitreous haemorrhage (leakage of blood into the areas in and around the vitreous humor of the eye), retinal tears and/or detachment.
Where is the study run from?
Department of Opthalmology, Catholic University of Sacro Cuore (Italy).
When is the study starting and how long is it expected to run for?
The study started in December 2010 and the study ran until July 2012.
Who is funding the study?
Catholic University of Sacro Cuore (Italy)
Who is the main contact?
Dr Edoardo Abed
Contact information
Scientific
Largo Agostino Gemelli
8 Department of Ophthalmology Catholic University of Sacro Cuore
Rome
00168
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Assessment of retinal function before and after idiopathic macular hole surgery: a randomised trial |
| Study objectives | To compare functional outcomes of vitrectomy and internal limiting membrane peeling assisted by intravitreal injection of triamcinolone acetonide or infracyanine green for idiopathic macular hole. |
| Ethics approval(s) | Catholic University of Sacro Cuore Ethics Committee, 08 November 2010 |
| Health condition(s) or problem(s) studied | Idiopathic macular hole |
| Intervention | Patients were divided in two arms of 15 patients each. Patients of the first arm underwent pars plana vitrectomy and internal limiting membrane peeling assisted by intravitreal injection of triamcinolone acetonide. Patients of the second arm underwent pars plana vitrectomy and internal limiting membrane peeling assisted by staining with infracyanine green. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Visual acuity measured with Snellen chart before surgery, 7 days and 1, 3, 6 and 12 months after surgery. |
| Key secondary outcome measure(s) |
Fundus microperimetry with MP-1 before surgery and 1, 3, 6 and 12 months after surgery |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Full thickness idiopathic macular hole (stage II, III or IV of Gass Classification) diagnosed and staged by slit-lamp fundus examination, using a 90-diopter lens and spectral domain optical coherence tomography |
| Key exclusion criteria | 1. Visual acuity worse than 1.0 (logMAR) 2. Previous macular surgery 3. Corneal opacities 4. Macular diseases other than macular hole 5. Optic nerve atrophy 6. Phakic patients |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
00168
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
