Condition category
Eye Diseases
Date applied
14/11/2012
Date assigned
27/11/2013
Last edited
27/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Edoardo Abed

ORCID ID

Contact details

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

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

http://www.unicattolica.it/

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

Publication citations

Additional files

Editorial Notes