Assessment of retinal function before and after idiopathic macular hole surgery

ISRCTN	ISRCTN31177220
DOI	https://doi.org/10.1186/ISRCTN31177220
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Edoardo Abed
Scientific

Largo Agostino Gemelli
8 Department of Ophthalmology Catholic University of Sacro Cuore
Rome
00168
Italy

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/12/2010
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Largo Agostino Gemelli

Rome
00168
Italy

Sponsor information

Catholic University of Sacro Cuore (Italy)
University/education

Largo Agostino Gemelli, 8
Rome
00168
Italy

Website	http://www.unicattolica.it/
"ROR"	https://ror.org/03h7r5v07

Funders

Funder type

University/education

Catholic University of Sacro Cuore (Italy)

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