Actively Recruiting
Optimizing the Ocular Surface With Systane COMPLETE Before and After Cataract Surgery in Patients With Dry Eye: An Extension Study
Led by National Taiwan University Hospital · Updated on 2026-04-24
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with dry eye who are planning to have cataract surgery. It aims to compare corneal astigmatism data before and after using a specific artificial tear called Systane COMPLETE to see how it affects predicting changes in astigmatism after surgery. The study also looks at how using or not using this product influences dry eye symptoms measured by Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT). Cataract surgery can worsen dry eye symptoms and impact measurements important for lens correction during surgery, which this study seeks to address. Participants are divided into two groups: an experimental group and a control group. The experimental group uses Systane COMPLETE one month before cataract surgery and continues using it for one month starting one week after surgery. The control group meets the same age and dry eye criteria but does not receive any treatment. This extension study follows up on an earlier trial and adds a post-surgery period to assess the effects of Systane COMPLETE on eye measurements and dry eye symptoms. Participants will undergo assessments before and after surgery, including measurements of corneal astigmatism, refractive power, and biometry parameters. They will also complete questionnaires about dry eye symptoms (OSDI) and have their tear stability measured (NITBUT). The study monitors changes from before treatment to one to two months after using Systane COMPLETE. The total planned enrollment is 140 participants, with equal numbers in each group. Researchers aim to improve management of dry eye and astigmatism prediction in cataract surgery patients.
CONDITIONS
Brief Title
Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cataract patients aged 20 to 85 years
- Patients with dry eye symptoms planning to undergo cataract surgery
- Patients with normal cognitive function able to complete the dry eye questionnaire
- For experimental group: Participation in the previous Systane COMPLETE trial without withdrawal
- Willingness to undergo cataract surgery with intraocular lens implantation under topical anesthesia
You will not qualify if you...
- Patients unwilling to participate after surgery (experimental group)
- Unable to answer dry eye survey questions (control group)
- History of ocular trauma or surgery in the planned surgical eye
- Active ocular infection
- Obvious abnormalities in ocular surface or eyelid margins other than meibomian gland dysfunction
- Corneal abnormalities or epithelial defects shown by positive corneal fluorescein staining
- Current use of systemic drugs such as tetracycline derivatives, antihistamines, or isotretinoin
- Using dry eye medication at screening stage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants in the experimental group use Systane COMPLETE artificial tears for one month before cataract surgery and continue using it for one month starting one week after surgery. The control group does not receive this treatment.
Multiple visits before and after surgery depending on treatment schedule
Duration - 1 month post-surgery
Participants are monitored for changes in corneal astigmatism, dry eye symptoms, and tear film stability after cataract surgery.
Several follow-up visits during the month after surgery
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
C
Chiun Ho Hou, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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