Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

NCT03045367 | Completed DMC

• 1 other identifier: CS/526
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epiretinal Membrane; Cataract Senile

Keywords

Metamorphopsia; Epiretinal membrane; Vitrectomy

Outcome Measures

Primary Outcomes (4)

• Metamorphopsia

  Change in spatial degree of distortion perception

  Change in metamorphopsia from baseline at 180 days.

• Visual Acuity

  Change in LogMAR visual acuity

  Change in visual acuity from baseline at 180 days

• Area of central scotoma

  Change in area, in square pixel, of central scotoma

  Change in area of central scotoma from baseline at 180 days

• Central fovea thickness

  Change in fovea thickness in µm at the Sd OCT

  Change in fovea thickness from baseline at 180 days

Study Arms (1)

Outpatients

Phacoemulsification, intraocular lens implant, vitrectomy.

Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.

Interventions

Phacoemulsification, intraocular lens implant, vitrectomy. PROCEDURE

Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.

Outpatients

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient of all gender, with complain of visual impairment and distortion

You may qualify if:

• age \> 55 years
• visual acuity ≤ 20/40
• idiopathic epiretinal membrane
• cataract
• Amsler test positive for metamorphopsia.

You may not qualify if:

• previous ocular interventions
• other ocular diseases.

Sponsors & Collaborators

• Clinica Oculistica dell'Università di Torino: lead

MeSH Terms

Conditions

Epiretinal Membrane; Vision Disorders

Interventions

Phacoemulsification; Lens Implantation, Intraocular; Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: June 22, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02