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Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients

Phase 4
Completed
Conditions
Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid
Interventions
Drug: Routine preoperative and postoperative anti-infection therapy
Drug: artificial tear therapy
Procedure: Cleaning, hot compresses and massage of the meibomian gland
Registration Number
NCT05771194
Lead Sponsor
Tianjin Medical University Eye Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group BRoutine preoperative and postoperative anti-infection therapyOn the basis of group A,Group B was given 0.1% sodium hyaluronate eye drops 4 times daily for 3 days before surgery (Jiang Xi, Zhen Shiming Pharmaceutical Co., Ltd.) and 3 months after surgery, and one cleaning, hot compresses and massage of the meibomian gland.
group Bartificial tear therapyOn the basis of group A,Group B was given 0.1% sodium hyaluronate eye drops 4 times daily for 3 days before surgery (Jiang Xi, Zhen Shiming Pharmaceutical Co., Ltd.) and 3 months after surgery, and one cleaning, hot compresses and massage of the meibomian gland.
group BCleaning, hot compresses and massage of the meibomian glandOn the basis of group A,Group B was given 0.1% sodium hyaluronate eye drops 4 times daily for 3 days before surgery (Jiang Xi, Zhen Shiming Pharmaceutical Co., Ltd.) and 3 months after surgery, and one cleaning, hot compresses and massage of the meibomian gland.
group ARoutine preoperative and postoperative anti-infection therapyGroup A received conventional preoperative and postoperative anti-infective therapy.
Primary Outcome Measures
NameTimeMethod
The average non-invasive tear film break-up time5minutes to 10 minutes

The NITBUT values were measured using a non-invasive ophthalmic analyser; the patients were instructed to blink 2 times after a normal blink, focus their eyes, and then refrain from blinking until the Placido ring projected onto the cornea was broken; the duration was recorded.

Secondary Outcome Measures
NameTimeMethod
meibomian gland loss1minutes to 5 minutes

The Meibo-Scan mode was selected. Then, the upper and lower eyelids were turned outward, and morphological images of the meibomian glands were obtained under an infrared light source. The shortening and loss of meibomian glands were observed and recorded on the following scale: The absence of meibomian gland loss (MGL) corresponded to a score of 0 point, an MGL ratio of less than 1/3 was assigned 1 point, an MGL ratio of 1/3 to 2/3 received 2 points, and a ratio of \>2/3 received 3 points.

lipid layer thickness1minutes to 5 minutes

The LipiView interferometer was used for examination under natural light. The patient was in a sitting position, and the mandible and forehead were against the jaw bracket and the forehead bracket, respectively. The aiming frame was aligned between the pupil and the lower eyelid margin; the position was adjusted until the reflection of the lower eyelashes was clear. Patients were asked to gaze at the light source for approximately 20 s and blink normally. The average LLT were recorded.

non-invasive measured tear meniscus height1minutes to 5 minutes

The lacrimal river was imaged, and the height of the lacrimal river directly below the centre of the pupil was measured with the built-in measurement tool of the system. Each patient was examined by the same ophthalmologist three times, and the average of the three measurements was used as the final result.

Trial Locations

Locations (1)

Tianjin medical university eye hosipital

🇨🇳

Tianjin, Tianjin, China

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