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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03705949

Enrollment

180

Registered

2018-10-15

Start date

2017-09-15

Completion date

2018-09-15

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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

Interventions

DRUGSodium Hyaluronate 0.1% drops

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

DRUGSodium Hyaluronate 0.2% drops

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Surface Discomfort Index	6 weeks	A subjective parameter that quantifies corneal discomfort

Secondary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026