Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort 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 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), 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].

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Sodium Hyaluronate 0.1% drops
* Drug: Sodium Hyaluronate 0.2% drops


Participation Criteria
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Eligibility Criteria
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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: Diagnosis or evidence of dry-eye-disease (DED) IOP-lowering medications Former incisional surgery Former diagnosis of corneal disease Diabetes Autoimmune diseases Mental diseases

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Study group<br>Sodium Hyaluronate 0.1% drops | Drug: Sodium Hyaluronate 0.2% drops<br>* Patients will be administered Drops of Sodium Hyaluronate 0.2% quid<br>* Other names: Sodium Hyaluronate 0.2% drops (artificial tear medication);|
| Active Comparator: Control group<br>Sodium Hyaluronate 0.2% drops | Drug: Sodium Hyaluronate 0.1% drops<br>* Patients will be administered Drops of Sodium Hyaluronate 0.1% quid<br>* Other names: Sodium Hyaluronate 0.1% drops (artificial tear medication);|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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