Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Assessment of retinal function before and after idiopathic macular hole surgery: a randomised trial
Acronym
Study hypothesis
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
Catholic University of Sacro Cuore Ethics Committee, 08 November 2010
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. Visual acuity measured with Snellen chart before surgery, 7 days and 1, 3, 6 and 12 months after surgery.
2. Anatomical outcomes and macular hole closure evaluated by spectral domain optical coherence tomography.
3. Focal electroretinography of the central 2 and 16 degrees of the retina measured before surgery, 1 and 7 days and 1, 3, 6 and 12 months after surgery.
Secondary outcome measures
Fundus microperimetry with MP-1 before surgery and 1, 3, 6 and 12 months after surgery
Overall trial start date
01/12/2010
Overall trial end date
31/07/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/12/2010
Recruitment end date
31/07/2012
Locations
Countries of recruitment
Italy
Trial participating centre
Largo Agostino Gemelli
Rome
00168
Italy
Sponsor information
Organisation
Catholic University of Sacro Cuore (Italy)
Sponsor details
Largo Agostino Gemelli
8
Rome
00168
Italy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Catholic University of Sacro Cuore (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary