Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery

October 11, 2018 updated by: Georgios Labiris, Democritus University of Thrace

Impact of 0.1% Sodium Hyaluronate and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Cataract Extraction Surgery, a Comparative Study

Primary objective of the study is the assessment of the patients' discomfort 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), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens 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 fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].

Study Type

Interventional

Enrollment (Actual)

180

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
        • University Hospital of Alexandroupolis

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

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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. Diagnosis or evidence of dry-eye-disease (DED)
  2. IOP-lowering medications
  3. Former incisional surgery
  4. Former diagnosis of corneal disease
  5. Diabetes
  6. Autoimmune diseases
  7. Mental diseases

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: Study group
Sodium Hyaluronate 0.1% drops
Drug: Sodium Hyaluronate 0.2% drops
Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
Other Names:
  • Sodium Hyaluronate 0.2% drops (artificial tear medication)
Active Comparator: Control group
Sodium Hyaluronate 0.2% drops
Drug: Sodium Hyaluronate 0.1% drops
Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
Other Names:
  • Sodium Hyaluronate 0.1% drops (artificial tear medication)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface Discomfort Index
Time Frame: 6 weeks
A subjective parameter that quantifies corneal discomfort
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Break up time
Time Frame: 6 weeks
An objective parameter that quantifies stability of tear film
6 weeks
Central Corneal Sensitivity
Time Frame: 6 weeks
An objective parameter that quantifies corneal sensitivity
6 weeks

Collaborators and Investigators

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

Sponsor

Democritus University of Thrace

Collaborators

George Papanicolaou Hospital
Naval Hospital, Athens
Athinaiki General Clinic

Investigators

  • Study Director: Georgios Labiris, MD, PhD, University Hospital of Alexandroupolis, Democritus University of Thrace

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 (Actual)

September 15, 2017

Primary Completion (Actual)

September 15, 2018

Study Completion (Actual)

September 15, 2018

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 226/15-03-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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