Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

September 22, 2015 updated by: Georgios Labiris, Democritus University of Thrace

Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Eye Institute Of thrace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Systane Ultra
Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
Other Names:
  • Administration of Systane Ultra (Alcon)
Active Comparator: Control group
Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]
Drug: tobradex quid (Standard)
Standard medication (tobradex quid for 20 days)
Other Names:
  • Standard Medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Principal Investigator: Georgios Labiris, MD, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBCat

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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