Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

NCT03958292 | Completed

• 1 other identifier: OSFFE_OCU_IO18
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.

Conditions

Endophthalmitis Following Cataract Surgery

Keywords

Cataract; Endophthalmitis; Microbiological evaluation

Outcome Measures

Primary Outcomes (1)

• Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery

  Variation/Eradication of bacterial load in participants with positive culture at the screening visit. This variation/Eradication will be recorded at pre-surgical visit by means of a second collection of a conjunctival swab and culture analysis. This outcome will be assessed by comparing the number of participants undergoing eradication of their initial bacterial load or decrease of bacterial load after treatment.

  Three days of treatment

Study Arms (1)

Patients undergoing routine cataract surgery

EXPERIMENTAL

Two eye drops containing PVP-Iodine instillation in the eye undergoing cataract surgery three times for three days before surgery. Each patient was evaluated for conjunctival flora variation by means of two conjunctival swabs before starting the treatment and at the end of the treatment before the surgery.

Device: IODIM

Interventions

IODIM DEVICE

Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides

Patients undergoing routine cataract surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Males and females aged between 40 and 80 years
• Patients who are candidates for cataract extraction

You may not qualify if:

• Males and females under 40 years and over 80 years
• Previous diseases of the eye, ocular surface and thyroid disease
• Known hypersensitivity to the product
• Presence of autoimmune diseases
• Pregnancy or breast-feeding
• Participation in other clinical studies

Sponsors & Collaborators

• Ospedale Sacra Famiglia - Fatebenefratelli Erba: lead

Study Sites (6)

Oftalmologia Universitaria Ospedale Policlinico di Bari

Bari, BA, 70120, Italy

Location

Ospedale Sacra Famiglia Fatebenefratelli

Erba, Como, 22036, Italy

Location

Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico

Catania, CT, 95123, Italy

Location

Centro di Microchirurgia Ambulatoriale di Monza

Monza, MB, 20900, Italy

Location

Casa di Cura Villa Valeria di Roma

Roma, RM, 00141, Italy

Location

Ospedale San Carlo di Nancy

Roma, RM, 00165, Italy

Location

MeSH Terms

Conditions

Cataract; Endophthalmitis

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Eye Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient has self-control of the IODIM treatment in the eye undergoing to cataract surgery with the contralateral eye. Microbiological studies will be performed by means of conjunctival swabs evaluation.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 22, 2019
• Study Start: January 8, 2018
• Primary Completion: October 29, 2018
• Study Completion: March 30, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

IT (6)