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

NCT05771194 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-16

No results posted yet for this study

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

Interventions

DRUG

Routine preoperative and postoperative anti-infection therapy

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.

DRUG

artificial tear therapy

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.

PROCEDURE

Cleaning, hot compresses and massage of the meibomian gland

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.

Sponsors & Collaborators

  • Tianjin Medical University Eye Hospital

    lead OTHER

Principal Investigators

  • Bo-Jie Hu · Tianjin Medical University Eye Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-03-20
Completion
2022-07-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771194 on ClinicalTrials.gov