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Completed

NCT Number: NCT03705949

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Hyaluronate 0.1% drops

Drug

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

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

Sodium Hyaluronate 0.2% drops

Drug

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

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

Primary outcomes

  1. Surface Discomfort Index

    Time frame: 6 weeks

    A subjective parameter that quantifies corneal discomfort

Secondary outcomes

  1. Break up time

    Time frame: 6 weeks

    An objective parameter that quantifies stability of tear film

  2. Central Corneal Sensitivity

    Time frame: 6 weeks

    An objective parameter that quantifies corneal sensitivity

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Collaborators

  • Athinaiki General Clinic
  • George Papanicolaou Hospital
  • Naval Hospital, Athens

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2018
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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