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

T

Tianjin Medical University Eye Hospital

Status and phase

Completed
Phase 4

Conditions

Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05771194
hbj112233

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

group A
Experimental group
Description:
Group A received conventional preoperative and postoperative anti-infective therapy.
Treatment:
Drug: Routine preoperative and postoperative anti-infection therapy
group B
Active Comparator group
Description:
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.
Treatment:
Drug: artificial tear therapy
Procedure: Cleaning, hot compresses and massage of the meibomian gland
Drug: Routine preoperative and postoperative anti-infection therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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