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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705949
• Other study ID #: 226/15-03-2018
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: September 15, 2018

Study information

• Verified date: October 2018
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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:

1. Diagnosis or evidence of dry-eye-disease (DED)

2. IOP-lowering medications

3. Former incisional surgery

4. Former diagnosis of corneal disease

5. Diabetes

6. Autoimmune diseases

7. Mental diseases

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Sodium Hyaluronate 0.1% drops
Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
• Sodium Hyaluronate 0.2% drops
Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (4)

Lead Sponsor	Collaborator
Democritus University of Thrace	Athinaiki General Clinic, George Papanicolaou Hospital, Naval Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface Discomfort Index	A subjective parameter that quantifies corneal discomfort	6 weeks
Secondary	Break up time	An objective parameter that quantifies stability of tear film	6 weeks
Secondary	Central Corneal Sensitivity	An objective parameter that quantifies corneal sensitivity	6 weeks