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

ConditionOphthalmology
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-85
SponsorNational Taiwan University Hospital

About this trial

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 not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systane Complete

    Drug

    Systane COMPLETE is an artificial tears that contain nano-emulsion of mineral oil and phospholipids.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Systane COMPLETEExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The change of the keratometry data before and after using Systane COMPLETE

The change of the keratometry data is assessed for investigating ocular surface stability after using Systane COMPLETE. The keratometry data is measured using auto-refractor.

Time frame
1-2 months

Secondary outcomes

1

The change of the refractive power before and after using Systane COMPLETE

The change of the refractive power is assessed for investigating ocular surface stability after using Systane COMPLETE. The refractive power measurement is completed using auto-refractor.

Time frame
1-2 months
2

The change of the biometry parameter before and after using Systane COMPLETE

The change of the biometry parameters ( ocular length, anterior chamber depth, lens thickness) are assessed for investigating ocular surface stability after using Systane COMPLETE. The biometry parameters is measured using Eyestar 900 (Haag-Streit Diagnostics, Switzerland).

Time frame
1-2 months
3

The change of corneal topology map before and after using Systane COMPLETE

The change of the corneal topology map is assessed for investigating ocular surface stability after using Systane COMPLETE. The corneal topology map is completed using Pentacam (OCULUS, German), and the corneal optical power is measured.

Time frame
1-2 months
4

The change of Ocular Surface Disease Index (OSDI) before and after using Systane COMPLETE

Whether Systane COMPLETE relieve dry eye symptoms subjetively is evaluated using the Ocular Surface Disease Index (OSDI) questionnaire. The OSDI questionnaire focuses on three aspects: self-reported eye discomfort, visual function impairment, and environmental triggers. The questionnaire contains 12 items, each rated on a scale from 0 to 4, with a total score ranging from 0 to 100. Higher scores indicate more severe dry eye symptoms. The OSDI questionnaire has high reliability and validity, aiding healthcare professionals in quickly assessing the severity of dry eye, making it suitable for clinical diagnosis and treatment evaluation.

Time frame
1-2 months

Other outcomes

Sponsors and contacts

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