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

Democritus University of Thrace

Status: Completed

Conditions: Cataract

Treatments: Drug: Sodium Hyaluronate 0.1% drops; Drug: Sodium Hyaluronate 0.2% drops

Study type: Interventional

Funder types: Other

Identifiers

NCT03705949

226/15-03-2018

Details and patient eligibility

About

Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Full 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].

Enrollment: 180 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Study group

Active Comparator group

Description:

Sodium Hyaluronate 0.1% drops

Treatment:

Drug: Sodium Hyaluronate 0.2% drops

Control group

Active Comparator group

Description:

Sodium Hyaluronate 0.2% drops

Treatment:

Drug: Sodium Hyaluronate 0.1% drops