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Not yet recruiting NCT07581548

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

— Observational Cataract Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max), Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo), Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra).
Who it may be relevant to
Registry conditions: Cataract, Dry Eye. Basic parameters: 45 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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
  • 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

Primary outcome measures

  • Ocular Surface Disease Index (OSDI) [Time frame: 12 weeks]
  • Tear Break-up Time (TBUT) [Time frame: 12 weeks]
Secondary outcome measures (2)
  • Schirmer test (basal tear production) [Time frame: 12 weeks]
  • Efron scale for bulbar redness [Time frame: 12 weeks]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • University Hospital of Alexandroupolis — Alexandroupoli

Publications

  • Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017. PMID 28497070
  • 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. PMID 30805405

Identifiers

NCT: NCT07581548 · ES10/Th23/20-04-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗