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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Sodium Hyaluronate 0.1% drops

Sodium Hyaluronate 0.2% drops

About this trial

This is an interventional prevention trial for Cataract

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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:

Diagnosis or evidence of dry-eye-disease (DED)
IOP-lowering medications
Former incisional surgery
Former diagnosis of corneal disease
Diabetes
Autoimmune diseases
Mental diseases

Sites / Locations

University Hospital of Alexandroupolis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Study group

Control group

Arm Description

Sodium Hyaluronate 0.1% drops

Sodium Hyaluronate 0.2% drops

Outcomes

Primary Outcome Measures

Surface Discomfort Index

A subjective parameter that quantifies corneal discomfort

Secondary Outcome Measures

Break up time

An objective parameter that quantifies stability of tear film

Central Corneal Sensitivity

An objective parameter that quantifies corneal sensitivity

Full Information

NCT ID

NCT03705949

First Posted

October 11, 2018

Last Updated

October 11, 2018

Sponsor

Democritus University of Thrace

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03705949

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 15, 2017 (Actual)

Primary Completion Date

September 15, 2018 (Actual)

Study Completion Date

September 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Democritus University of Thrace

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Active Comparator

Arm Description

Sodium Hyaluronate 0.1% drops

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Sodium Hyaluronate 0.2% drops

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate 0.1% drops

Other Intervention Name(s)

Sodium Hyaluronate 0.1% drops (artificial tear medication)

Intervention Description

Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate 0.2% drops

Other Intervention Name(s)

Sodium Hyaluronate 0.2% drops (artificial tear medication)

Intervention Description

Patients will be administered Drops of Sodium Hyaluronate 0.2% quid

Primary Outcome Measure Information:

Title

Surface Discomfort Index

Description

A subjective parameter that quantifies corneal discomfort

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Break up time

Description

An objective parameter that quantifies stability of tear film

Time Frame

6 weeks

Title

Central Corneal Sensitivity

Description

An objective parameter that quantifies corneal sensitivity

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georgios Labiris, MD, PhD

Organizational Affiliation

University Hospital of Alexandroupolis, Democritus University of Thrace

Official's Role

Study Director

Facility Information:

Facility Name

University Hospital of Alexandroupolis

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

68100

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

30805405

Citation

Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019.

Results Reference

derived

Learn more about this trial

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

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