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Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02558218
First Posted: September 23, 2015
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace
  Purpose
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.

Condition Intervention
Cataract Drug: Systane Ultra Drug: tobradex quid (Standard)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation

Resource links provided by NLM:


Further study details as provided by Georgios Labiris, Democritus University of Thrace:

Primary Outcome 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 Outcome 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


Enrollment: 80
Study Start Date: January 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Standard Medication

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).
  Eligibility

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Ages Eligible for Study:   55 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558218


Locations
Greece
Eye Institute Of thrace
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
Principal Investigator: Georgios Labiris, MD, PhD Assistant Professor
  More Information

Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT02558218     History of Changes
Other Study ID Numbers: FBCat
First Submitted: September 15, 2015
First Posted: September 23, 2015
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases


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