Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery
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|ClinicalTrials.gov Identifier: NCT03045367|
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Clinica Oculistica dell'Università di Torino
Information provided by (Responsible Party):
Marco DAL VECCHIO, MD, Clinica Oculistica dell'Università di Torino
This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.
|Condition or disease||Intervention/treatment|
|Epiretinal Membrane Cataract Senile||Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||30 participants|
|Target Follow-Up Duration:||180 Days|
|Official Title:||Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery|
|Actual Study Start Date :||June 22, 2015|
|Actual Primary Completion Date :||October 31, 2016|
|Actual Study Completion Date :||October 31, 2016|
Phacoemulsification, intraocular lens implant, vitrectomy.
Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.
Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.
Primary Outcome Measures :
- Metamorphopsia [ Time Frame: Change in metamorphopsia from baseline at 180 days. ]Change in spatial degree of distortion perception
- Visual Acuity [ Time Frame: Change in visual acuity from baseline at 180 days ]Change in LogMAR visual acuity
- Area of central scotoma [ Time Frame: Change in area of central scotoma from baseline at 180 days ]Change in area, in square pixel, of central scotoma
- Central fovea thickness [ Time Frame: Change in fovea thickness from baseline at 180 days ]Change in fovea thickness in µm at the Sd OCT
No Contacts or Locations Provided