Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT02558218
• Date of registration: 15/09/2015
• Prospective Registration: No
• Primary sponsor: Democritus University of Thrace
• Public title: Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
• Scientific title: Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
• Date of first enrolment: January 2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02558218
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Georgios Labiris, MD, PhD
• Affiliation: Assistant Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the -
Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

1. Endothelial cell count less than 1900,

2. Glaucoma,

3. IOP-lowering medications,

4. Former incisional surgery,

5. Former diagnosis of corneal disease,

6. Diabetes or autoimmune diseases

7. Former diagnosis of dry eye disease



Age minimum: 55 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cataract

Intervention(s)

Drug: Systane Ultra

Drug: tobradex quid (Standard)

Primary Outcome(s)

Foreign body sensation [Time Frame: 1 month postoperatively]

Secondary Outcome(s)

Ocular Redness [Time Frame: 7 days postoperatively]

Corneal Sensitivity [Time Frame: 1 month postoperatively]

Secondary ID(s)

FBCat

Source(s) of Monetary Support

Please refer to primary and secondary sponsors