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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05771194
Enrollment
40
Registered
2023-03-16
Start date
2021-02-01
Completion date
2022-07-02
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGRoutine 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.

DRUGartificial 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.

PROCEDURECleaning, 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

Tianjin Medical University Eye Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The average non-invasive tear film break-up time5minutes to 10 minutesThe 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

MeasureTime frameDescription
lipid layer thickness1minutes to 5 minutesThe 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 minutesThe 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.
meibomian gland loss1minutes to 5 minutesThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026