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NCT Number: NCT07581548

Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery

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.

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Key information

Conditions

Cataract Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location contact

Dimitrios Aggelonias, MSc

CONTACT

[email protected]

+30 2551030990

Eirini - Kanella Panagiotopoulou

CONTACT

[email protected]

Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

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

  • Former incisional surgery
  • Former diagnosis of corneal disease
  • Autoimmune diseases
  • Mental diseases

Treatment and study plan

Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)

Drug

Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen

Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)

Drug

Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen

Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)

Drug

Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 12 weeks

    A subjective parameter that quantifies corneal discomfort

  2. Tear Break-up Time (TBUT)

    Time frame: 12 weeks

    An objective parameter that quantifies stability of tear film

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

CONTACT

[email protected]

+30 6978730858

Georgios Labiris, MD, Prof

CONTACT

[email protected]

+30 2551030990

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Acronym: DRY-CAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

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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