Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Overview

Primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Full Title of Study: “Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Detailed Description

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group (who will receive Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).

Interventions

  • Drug: Systane Ultra
    • Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
  • Drug: tobradex quid (Standard)
    • Standard medication (tobradex quid for 20 days)

Arms, Groups and Cohorts

  • Active Comparator: Systane ultra group
    • Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.
  • Active Comparator: Control group
    • Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]

Clinical Trial Outcome Measures

Primary Measures

  • Foreign body sensation
    • Time Frame: 1 month postoperatively
    • Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day

Secondary Measures

  • Ocular Redness
    • Time Frame: 7 days postoperatively
    • Ocular redness will be assessed by means of a validated photographic chart
  • Corneal Sensitivity
    • Time Frame: 1 month postoperatively
    • Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Democritus University of Thrace
  • Provider of Information About this Clinical Study
    • Principal Investigator: Georgios Labiris, Assistant Professor – Democritus University of Thrace
  • Overall Official(s)
    • Georgios Labiris, MD, PhD, Principal Investigator, Assistant Professor

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