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

NCT05771194 | Completed Phase 4

• 1 other identifier: hbj112233
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The average non-invasive tear film break-up time

  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.

  5minutes to 10 minutes

Secondary Outcomes (3)

• lipid layer thickness

  1minutes to 5 minutes

• non-invasive measured tear meniscus height

  1minutes to 5 minutes

• meibomian gland loss

  1minutes to 5 minutes

Study Arms (2)

group A

EXPERIMENTAL

Group A received conventional preoperative and postoperative anti-infective therapy.

Drug: Routine preoperative and postoperative anti-infection therapy

group B

ACTIVE COMPARATOR

On 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.

Drug: Routine preoperative and postoperative anti-infection therapy; Drug: artificial tear therapy; Procedure: Cleaning, hot compresses and massage of the meibomian gland

Interventions

Routine preoperative and postoperative anti-infection therapy DRUG

received gatifloxacin eye drops (Otsuka Pharmaceutical Co., Ltd.) 4 times daily and gatifloxacin eye ointment once every night (Shenyang Xing Qi Pharmaceutical Co., Ltd) for 3 days before surgery. Postoperatively, gatifloxacin eye drops were administered 4 times daily, 0.1% fluorometholone (San Tian Pharmaceutical Co., Ltd., China) was administered 4 times daily, and pranoprofen (Qian Su Pharmaceutical Co., Ltd., Japan) was administered 4 times daily. The doses of the above three drugs were reduced each week. The compound tropicamide was administered once a day (Shentian Pharmaceutical Co., Ltd., China). All of the above procedures were stopped 1 month after surgery.

group A; group B

artificial tear therapy DRUG

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.

group B

Cleaning, hot compresses and massage of the meibomian gland PROCEDURE

Group B used a steam eye mask (Your Ga Run Fang, Shang Hai Run Mu Industrial Co., Ltd.) for 20 minutes 3 days before surgery. Sterile cotton swabs were used to apply physiological saline to the eyelid for local cleaning, and the secretions and phosphorus debris on the surface of the eyelid margin were removed to fully expose the meibomian gland. Meibomian gland tweezers were used to squeeze from the root of the gland toward the opening to expel the secretions; each gland was expressed twice. After the operation, an appropriate amount of gatifloxacin cream (Shen Yang Xing Qi Pharmaceutical Co., Ltd.) was applied to the conjunctival sac to prevent infection. Hot towels (40°C) were applied to the eyes for 10 minutes every morning and evening for 3 days before the operation.

group B

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of dry eye
• Clinical diagnosis for MGD

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Bo-Jie Hu

  Tianjin Medical University Eye Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,head of ophthalmology;Principal Investigator

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 16, 2023
• Study Start: February 1, 2021
• Primary Completion: March 20, 2022
• Study Completion: July 2, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)