Back to resultsAnalysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
Primary Purpose
Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Routine preoperative and postoperative anti-infection therapy
artificial tear therapy
Cleaning, hot compresses and massage of the meibomian gland
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid focused on measuring Meibomian gland dysfunction, Dry eye, Non-invasive ocular surface analyser, Pars plana vitrectomy, ,Meibomian gland massage
Eligibility Criteria
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
Sites / Locations
- Tianjin medical university eye hosipital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
Group A received conventional preoperative and postoperative anti-infective therapy.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
lipid layer thickness
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 height
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.
meibomian gland loss
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.
Full Information
NCT ID
NCT05771194
First Posted
February 19, 2023
Last Updated
March 4, 2023
Sponsor
Tianjin Medical University Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05771194
Brief Title
Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
Official Title
Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
July 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
Group A received conventional preoperative and postoperative anti-infective therapy.
Arm Title
group B
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Routine preoperative and postoperative anti-infection therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
artificial tear therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cleaning, hot compresses and massage of the meibomian gland
Intervention Description
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.
Primary Outcome Measure Information:
Title
The average non-invasive tear film break-up time
Description
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.
Time Frame
5minutes to 10 minutes
Secondary Outcome Measure Information:
Title
lipid layer thickness
Description
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.
Time Frame
1minutes to 5 minutes
Title
non-invasive measured tear meniscus height
Description
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.
Time Frame
1minutes to 5 minutes
Title
meibomian gland loss
Description
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.
Time Frame
1minutes to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo-Jie Hu
Organizational Affiliation
Tianjin Medical University Eye Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin medical university eye hosipital
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients
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