Trial | NCT03705949  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    180
Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
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].
Study Started
Sep 15
2017
Primary Completion
Sep 15
2018
Study Completion
Sep 15
2018
Last Update
Oct 15
2018

Drug Sodium Hyaluronate 0.1% drops

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

  • Other names: Sodium Hyaluronate 0.1% drops (artificial tear medication)

Drug Sodium Hyaluronate 0.2% drops

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

  • Other names: Sodium Hyaluronate 0.2% drops (artificial tear medication)

Study group Active Comparator

Sodium Hyaluronate 0.1% drops

Control group Active Comparator

Sodium Hyaluronate 0.2% drops

Criteria 

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
No Results Posted