Health TrialsbyHealthPanel

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

ConditionsCataractDry Eye
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-85
SponsorDemocritus University of Thrace

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Former incisional surgery

Former diagnosis of corneal disease

Autoimmune diseases

Mental diseases

Trial population

Patients who underwent cataract extraction surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Study Group 11 intervention
Group B: Study Group 21 intervention
Group C: Study Group 31 intervention

Trial outcomes

Primary outcomes

1

Ocular Surface Disease Index (OSDI)

A subjective parameter that quantifies corneal discomfort

Time frame
12 weeks
2

Tear Break-up Time (TBUT)

An objective parameter that quantifies stability of tear film

Time frame
12 weeks

Secondary outcomes

1

Schirmer test (basal tear production)

An objective test that assesses basal tear production alone using topical anesthetic drops, by removing the stimulus that triggers reflex tearing.

Time frame
12 weeks
2

Efron scale for bulbar redness

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Democritus University of Thrace

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: