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Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery

ConditionAge-related Cataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with age-related cataract

Age 60 years or above

Disqualifiers

Unwilling to sign informed consent

Pseudoexfoliation syndrome

Functionally monocular patient

Any use of eye drops during at least 3 months before surgery with the exception of artificial tears

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preservative Free drop treatment

    Drug

    Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

  • Preserved drop treatment

    Drug

    Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Preservative-free dexamethasone 0.1%/diclofenac 0.1%Experimental treatment 1 intervention
Group B: Preserved dexamethasone 0.1%/diclofenac 0.1%Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The superiority of treatment arm without conservative (WC) on treatment arm with conservative (C) on the aqueous flare value in the operated eye, measured with a laser flare meter, at week 4 after cataract surgery.

The Laser Flaremeter can measure the protein density in the anterior chamber by counting the photons. Flare Value is expressed in photoncount/ms. 1-9 photoncounts/ms is a normal value. Photoncount/ms from 10-500 is abnormal and indicates an inflamed eye.

Time frame
4 weeks

Secondary outcomes

1

Tear Osmolarity

The difference in Tear Osmolarity between the two treatment arms. Tear Osmolarity value will be measured with TearLab.

Time frame
4 weeks
2

Conjunctival Hyperemia

The difference in Conjunctival Hyperemia between the two treatment arms. The scale that will be used is the Cornea and Contact Lens Research Unit (CCLRU) scale. Minimum score is 1, maximum score is 4.

Time frame
4 weeks
3

Corneal Fluorescein Staining

The difference in Corneal Fluorescein Staining between the two treatment arms. The grading scale that will be used is the Oxford grading scale. Minimum score is grade 0, maximum score is grade 5.

Time frame
4 weeks
4

Tear-film break up time

The difference in Tear-film break up time between the two treatment arms. The Tear-film break up time will be expressed in seconds.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Laboratoires Thea

Collaborator

Source ClinicalTrials.gov
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