Status:

RECRUITING

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

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Ophthalmology

Eligibility:

All Genders

20-85 years

Phase:

PHASE4

Brief Summary

Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or...

Detailed Description

STUDY OBJECTIVE: Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism. Compare the effe...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Experimental group ): Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway.
  • Exclusion Criteria (Experimental group ): Patients unwilling to participate in this trial after surgery.
  • Inclusion Criteria(Control group):
  • Cataract patients aged between 20 and 85 years.
  • Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
  • Exclusion Criteria (Control group):
  • Unable to answer the questions in the dry eye survey.
  • Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
  • Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
  • Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
  • Using dry eye medication at screening stage.

Exclusion

    Key Trial Info

    Start Date :

    March 25 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2027

    Estimated Enrollment :

    140 Patients enrolled

    Trial Details

    Trial ID

    NCT06886373

    Start Date

    March 25 2025

    End Date

    December 31 2027

    Last Update

    November 18 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Taiwan University Hospital

    Taipei, Taiwan, 100