Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye

ConditionDry Eye
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorHe Eye Hospital

About this trial

Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 8-18 years old

Wearing corneal shape mirror more than one year and at least eight hours every night

Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.0.

Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.

Disqualifiers

Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens

Pathological changes in the corneal rim

Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);

Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • 3% Diquafosol tetrasodium

    Drug

    3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: DQS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pediatric Refractive Error Profile(PREP) questionnaire score

Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.

Time frame
Day-0 (baseline), 2-weeks, 4-weeks

Secondary outcomes

1

Non-invasive tear break-up time

Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

Time frame
Day-0 (baseline), 2-weeks, 4-weeks
2

Tear Film Lipid Layer

Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).

Time frame
Day-0 (baseline), 2-weeks, 4-weeks
3

Conjunctivocorneal staining grade

Using fluorescein sodium solution or fluorescein sodium test paper to contact the lower eyelid margin, corneal and conjunctival epithelial defects under the cobalt blue light of the slit lamp microscope showed different morphology, such as green spots, erosion, lamellar defects, ulcers and so on. The following categories: according to the severity of the symptoms can be mild, slit lamp microscope check no obvious signs of ocular surface damage (corneal fluorescein staining point \< 5); Moderate: the extent of corneal damage under the slit lamp microscope did not exceed 2 quadrants and (or) the number of corneal fluorescein staining spots was \>5 and \<30. Severe: the range of corneal damage was 2 quadrants or more and (or) the corneal fluorescent staining spots were more than 30. The fluorescein staining spots in the cornea fused into thick spots, sheets or with filaments.

Time frame
Day-0 (baseline), 2-weeks, 4-weeks
4

Tear meniscus height

Changes in TMH will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

Time frame
Day-0 (baseline), 2-weeks, 4-weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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