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Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Systane Ultra
tobradex quid (Standard)
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Institute Of thrace

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Systane ultra group

Control group

Arm Description

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.

Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]

Outcomes

Primary Outcome Measures

Foreign body sensation
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
Ocular redness will be assessed by means of a validated photographic chart
Corneal Sensitivity
Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day

Full Information

First Posted
September 15, 2015
Last Updated
September 22, 2015
Sponsor
Democritus University of Thrace
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1. Study Identification

Unique Protocol Identification Number
NCT02558218
Brief Title
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
Official Title
Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systane ultra group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.]
Intervention Type
Drug
Intervention Name(s)
Systane Ultra
Other Intervention Name(s)
Administration of Systane Ultra (Alcon)
Intervention Description
Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
Intervention Type
Drug
Intervention Name(s)
tobradex quid (Standard)
Other Intervention Name(s)
Standard Medication
Intervention Description
Standard medication (tobradex quid for 20 days)
Primary Outcome Measure Information:
Title
Foreign body sensation
Description
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
Time Frame
1 month postoperatively
Secondary Outcome Measure Information:
Title
Ocular Redness
Description
Ocular redness will be assessed by means of a validated photographic chart
Time Frame
7 days postoperatively
Title
Corneal Sensitivity
Description
Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day
Time Frame
1 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: Endothelial cell count less than 1900, Glaucoma, IOP-lowering medications, Former incisional surgery, Former diagnosis of corneal disease, Diabetes or autoimmune diseases Former diagnosis of dry eye disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Labiris, MD, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Institute Of thrace
City
Alexandroupolis
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
28497070
Citation
Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.
Results Reference
derived

Learn more about this trial

Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

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