Actively Recruiting

Phase 4
Age: 20Years - 85Years
All Genders
ID06763731

Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

Led by National Taiwan University Hospital · Updated on 2026-04-23

150

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

A

Alcon Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of regularly using Systane COMPLETE in patients with mixed dry eye who are planning to undergo cataract surgery. The study aims to see if this treatment can improve the accuracy of predicting residual astigmatism after surgery. Participants are adults aged 20 to 85 years with normal cognitive function who require cataract surgery with intraocular lens implantation. Participants will use Systane COMPLETE eye drops, applying 1 to 2 drops four times daily in both eyes for 1 to 2 months before surgery. The study includes a screening visit 1 to 2 months before surgery where demographic information, preoperative assessments, and dry eye evaluations are performed. Measurements of the cornea will be taken using specialized devices to monitor the ocular surface and detect irregularities. Seven days before surgery, participants will have repeat eye exams and biometry measurements to guide lens selection. On surgery day, participants will undergo cataract surgery with intraocular lens implantation, and medication use will be monitored through returned bottles and diaries. During the study, participants will complete questionnaires such as the OSDI Dry Eye Questionnaire and undergo vision and corneal surface assessments. Measurements include biometry and corneal topography, as well as non-invasive tear break-up time tests. These evaluations will occur at screening and pre-operative visits to track changes in the ocular surface. Compliance with treatment will be checked at surgery. The study will last until the end of 2027, focusing on optimizing the ocular surface to improve surgical outcomes for dry eye patients undergoing cataract surgery.

CONDITIONS

Brief Title

Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

Who Can Participate

Age: 20Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 20 to 85 years
  • Normal cognitive function and able to answer related questionnaires
  • Require phacoemulsification and intraocular lens implantation under topical anaesthesia
Not Eligible

You will not qualify if you...

  • Unable to answer questions in the dry eye survey
  • Ocular trauma or ocular surgery in the eye planned for surgery
  • Active ocular infection
  • Obvious abnormalities in ocular surface or eyelid margins other than meibomian gland dysfunction causing decreased vision other than cataracts
  • Corneal Fluorescein Staining positive indicating corneal abnormalities or epithelial defect
  • Use of systemic drugs including tetracycline derivatives, antihistamines, and isotretinoin
  • Using dry eye medication at screening stage

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 1 to 2 months before surgery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) where demographic information, pre-op assessments, and informed consent are completed

Treatment

Duration - 1 to 2 months

Participants use Systane COMPLETE eye drops regularly to optimize the ocular surface before cataract surgery.

Participants use the medication daily and attend 1 follow-up visit 7 days before surgery for assessments

Surgery

Duration - 1 day

Participants undergo phacoemulsification and intraocular lens implantation.

1 visit on the day of surgery including medication compliance check

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Actively Recruiting

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Research Team

C

Chiun Ho Hou, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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