Preventing dry eye disease in cataract surgery patients with diquafosol
The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
PHASE2 · Indonesia University · NCT06146881
This study is testing whether a new eye drop can help prevent dry eye disease in people having cataract surgery compared to a standard treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | Indonesia University (other) |
| Locations | 1 site (Jakarta Pusat, Jakarta) |
| Trial ID | NCT06146881 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of diquafosol sodium 3% compared to sodium hyaluronate 0.1% in preventing dry eye disease in patients undergoing cataract surgery. Participants will receive either treatment for four weeks prior to surgery and 21 days post-surgery. The study will assess subjective symptoms, objective signs of dry eye disease, tear osmolarity, and visual quality improvements. Key measurements will include the percentage reduction in symptoms and signs of dry eye, as well as changes in higher order aberrations and contrast sensitivity.
Who should consider this trial
Good fit: Ideal candidates are cataract patients with pre-existing dry eye disease who are scheduled for phacoemulsification and intraocular lens implantation.
Not a fit: Patients with serious ocular surface disorders or those who have had recent eye surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of dry eye disease in cataract surgery patients, improving their overall recovery and quality of life.
How similar studies have performed: While there have been studies on dry eye treatments, the specific use of diquafosol sodium 3% in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants 2. Patients with dry eye disease 3. Patients are willing to participate in the study and fill out informed consent Exclusion Criteria: 1. Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis) 2. There are complications after cataract surgery 3. Patients with a history of using topical medications / eye drops that are used routinely 4. History of eye surgery in the last 6 months 5. Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma) 6. Using regular medication that trigger dry eye conditions (eg antihistamines, antidepressants, decongestants, anticholinergics) / allergy to diquafosol drugs
Where this trial is running
Jakarta Pusat, Jakarta
- RSUPN Dr. Cipto Mangunkusumo — Jakarta Pusat, Jakarta, Indonesia (RECRUITING)
Study contacts
- Study coordinator: Natasya Claudia Santoso
- Email: thristded@gmail.com
- Phone: +6282132348778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dry Eye Disease, Dry eye disease