Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery (DRY-CAT)

May 6, 2026 updated by: Georgios Labiris, Democritus University of Thrace

Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery: A Non- Interventional, Observational Study

The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA). All participants will be randomly assigned to three study groups. Study group 1 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate & Dexpanthenol 2% (Hylopan max, Zwitter, Greece) quid for 12 weeks. Study group 2 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate & Trehalose 3% (Thealoz duo, Thea, Greece) quid for 12 weeks. Study group 3 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.2% sodium hyaluronate and amino acids (Helenvision Ultra, Pharmex, Greece) quid for 12 weeks.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Georgios Labiris, MD, Prof
  • Phone Number: +30 2551030990
  • Email: labiris@usa.net

Study Locations

  • Greece
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • University Hospital of Alexandroupolis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who underwent cataract extraction surgery

Description

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. Former incisional surgery
  2. Former diagnosis of corneal disease
  3. Autoimmune diseases
  4. Mental diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group 1
Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
Drug: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
Study Group 2
Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
Drug: Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
Study Group 3
Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Drug: Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: 12 weeks
A subjective parameter that quantifies corneal discomfort
12 weeks
Tear Break-up Time (TBUT)
Time Frame: 12 weeks
An objective parameter that quantifies stability of tear film
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer test (basal tear production)
Time Frame: 12 weeks
An objective test that assesses basal tear production alone using topical anesthetic drops, by removing the stimulus that triggers reflex tearing.
12 weeks
Efron scale for bulbar redness
Time Frame: 12 weeks
A clinical tool consisting of five photographic, color-calibrated images (graded 0 to 4) that allow practitioners to classify the severity of conjunctival hyperaemia, ranging from normal to severe Grade 0: Normal, pale eyelid margin, minimal conjunctival vessels. Grade 1: Trace/Very Slight redness. Grade 2: Slight/Mild redness. Grade 3: Moderate redness. Grade 4: Severe redness.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, MD, Prof, Democritus University of Thrace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES10/Th23/20-04-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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