Postoperative lubricating disorders after cataract surgery Eye Diseases
Conditions
Interventions
This trial includes four visits: one initial examination before cataract surgery (D0)
two follow-up examinations (D1 and D7) and one final examination (D35). The preoperative examination is before cataract surgery (D0). The follow-up examinations are defined in the trial protocol as da
Sponsors
URSAPHARM (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients >18 years 2. Age-appropriate cataract (uni- or bilateral) 3. Standard cataract surgery is possible, according to the surgeon 4. Preoperatively subjective complaints indicating a dry eye (foreign body sensation, dryness, burning, tearing, tired eyes) for at least 3 months: 4.1. VAS =2/10 4.2. OSDI =16 4.3. Fluorescein TBUT =10 s 5. Stable therapy (topical and systemic) =4 weeks 6. Patient is willing to participate in the trial 7. Patient is willing and able to fulfil the requirements of the trial protocol
Exclusion criteria
Exclusion criteria: 1. Dry eye due to systemic disease, concomitant medication, or malign conditions 2. Simultaneous preoperative use of other therapeutic ophthalmics 3. Ocular or systemic pathologies that could, according to the surgeon’s medical evaluation, have an influence on postoperative irritation (acute viral or bacterial inflammation of the conjunctiva/cornea, chronic inflammatory/infectious uveitis) 4. History of ocular surgery during the past 3 months 5. Malposition of the lids and/or lagophthalmos 6. Punctum plugs during the past 3 months 7. Contact lens wearers (no wearing of contact lenses 3 months before surgery) 8. Hypersensitivity against one of the ingredients of HYLO CARE® 9. Patient is a pregnant or breastfeeding woman 10. The patient is a woman with childbearing potential without the regular and correct use of contraception with error quote <1 % (e.g. sexual abstinence, estrogenic- and metagene-containing contraceptive, vasectomy, intrauterine pessary with hormones) 11. Concomitant participation in a clinical trial or another trial within the last 4 weeks and 4 weeks after the end of the trial 12. Earlier participation in this clinical trial or the patient being an investigator or a member of the personnel involved in this clinical trial. 13. Inability for linguistic or content comprehension of written patient information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Tear Break-up Time (TBUT) measured in seconds rounded to 1 decimal place using a non-automated method as described by Jacobi and Cursifen 2010 from first measurement preoperatively (D0) compared to measurement on day 35 (D35) ± 5 days (= 5 weeks) postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline (preoperative) values of ocular surface disease index using a standardized set of questions as defined in the Ocular Surface Disease Index (OSDI) questionnaire at D0 2. Subjective discomfort feeling according to the Symptom Assessment in Dry Eye (SANDE) patient questionnaire using a visual analogue scale (VAS) comparing baseline preoperatively (D0) to measurement on day 35 (D35) ± 5 days (= 5 weeks) postoperatively 3. Corrected visual acuity (VA) measured in decimal numbers with correction (cc) on D0, D1, D7 ± 3 and D35 ± 5 4. Slit lamp examination of eyelids, conjunctiva, and cornea by the investigator on D0, D1, D7 ± 3 and D35 ± 5: 4.1. Assessment of lid margins using a slit lamp 4.2. Assessment of conjunctiva (conjunctival hyperemia, chemosis) using a slit lamp 4.3. Corneal findings (corneal staining with fluorescein, corneal infiltrates, central corneal edema, descemet folds, corneal erosion) using a slit lamp 4.4. Assessment of the anterior chamber (flare and cells) using a slit lamp 5. Schirmer’s test (aqueous tear secretion) on D0 and D35±5 using test strips to determine the lubrication of the strip in mm 6. Intraocular pressure (IOP) measured using an applanatoric tonometric approach at D0, D1, D7 ± 3 and D35 ± 5 7. Subjective tolerability by the patient, assessed by questioning on day D7±2 and day D28±3 8. Evaluation of efficacy and tolerability by the investigator, assessed by questioning on day D35 ± 5 | — |
Countries
Germany
Contacts
Public ContactStefan Schorr
Outcome results
None listed