NCT03705949

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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 \[who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks\].

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Sodium Hyaluronate 0.1% drops	Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
DRUG	Sodium Hyaluronate 0.2% drops	Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Timeline

• Start date: 2017-09-15
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2018-10-15
• Last updated: 2018-10-15

Locations

1 site across 1 country: Greece