Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation

Conditions
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Cataract

Intervention / Treatment
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* Drug: Systane Ultra
* Drug: tobradex quid (Standard)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month postoperatively | 

Secondary Outcome Measures

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