Clinical trial NCT05771194: Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
Official title: Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid
Keywords: Meibomian gland dysfunction
Dry eye
Non-invasive ocular surface analyser
Pars plana vitrectomy
,Meibomian gland massage
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AIM: To observe ocular surface changes after phacovitrectomy in patients with mild to moderate meibomian gland dysfunction (MGD)-type dry eye and track clinical treatment response using a Keratograph 5M and a LipiView interferometer.

METHODS: Forty cases were randomized into control group A and treatment group B; the latter received meibomian gland treatment 3 days before phacovitrectomy and sodium hyaluronate before and after surgery. The average non-invasive tear film break-up time (NITBUTav), first non-invasive tear film break-up time (NITBUTf), non-invasive measured tear meniscus height (NTMH), meibomian gland loss (MGL), lipid layer thickness (LLT) and partial blink rate (PBR) were measured preoperatively and 1 week, 1 month and 3 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of dry eye
* Clinical diagnosis for MGD

Exclusion Criteria:

* eye trauma or eye surgery within the prior 6 months
* use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months
* other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy
* intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision
* long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber
* postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment
* the need for a second operation during the study follow-up eye trauma or eye surgery within the prior 6 months
* use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months
* other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy
* intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision
* long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber
* postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment
* the need for a second operation during the study follow-up

Primary outcomes:
measure: The average non-invasive tear film break-up time
timeFrame: 5minutes to 10 minutes
Secondary outcomes:
measure: lipid layer thickness
timeFrame: 1minutes to 5 minutes
measure: non-invasive measured tear meniscus height
timeFrame: 1minutes to 5 minutes
measure: meibomian gland loss
timeFrame: 1minutes to 5 minutes
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university eye hosipital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Bo-Jie Hu
role: STUDY_CHAIR
References: