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Assessment of retinal function before and after idiopathic macular hole surgery

Assessment of retinal function before and after idiopathic macular hole surgery: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31177220
Enrollment
30
Registered
2013-11-27
Start date
2010-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic macular hole Eye Diseases Other retinal disorders

Interventions

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 triamcino

Sponsors

Catholic University of Sacro Cuore (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Fundus microperimetry with MP-1 before surgery and 1, 3, 6 and 12 months after surgery

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026