The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap
Phase: NA
Conditions: Chronic Dacryocystitis
Sponsor: Eye & ENT Hospital of Fudan University

 
 
Clinical study protocol 
 
The Application of Photosensitive Hydrogel in Intranasal 
Endoscopic Dacryocystorhinostomy for the Anastomosis of 
Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap 
——A Prospective Randomized Controlled Single-center Clinical Study 
 
 
Principal investigator: Gong Lan 
 
Clinical Research Department: Ophthalmology 
Sponsor: No 
Solution version number: V1.0, February 1, 2023 
 
 
 
Principal Investigator Signature: 
                                          Date： 
 
 
 

 
Contact information for the principal investigator 
Eye, Ear, Nose and Throat Hospital of Fudan University     Ophthalmology 
Name：Gong Lan 
The title of a professional post： Chief physician 
Address：83 Fenyang Road 
Phone Number (Office) 
021-64377134-2281 
Cell phone 
13501798683 
Email address 
13501798683@139.com 
 
Contact information for members of the research group 
Name： Wang Yan 
The title of a professional post： Chief physician 
Address：83 Fenyang Road 
Phone Number (Office) 
021-64377134 
Cell phone 
15921971769 
Email address 
 wangyandoc@163.com 
 
Name： Lin Tong 
The title of a professional post：Attending physician 
Address：83 Fenyang Road 
Phone Number (Office) 
021-64377134 
Cell phone 
13585764906 
Email address 
Lintongwzmc@163.com 
 
 
 
 
 
 
 
 
 

1、Research background 
Chronic dacryocystitis is a common ophthalmic disease, mostly caused by nasolacrimal duct 
obstruction or stenosis. Tears and secretions cannot flow into the nasal cavity through the 
nasolacrimal duct and remain in the lacrimal sac, resulting in bacterial infection. If not treated, it 
can not only affect the patient's daily life, but also threaten the patient's eye health. The accumulation 
of pus in the lacrimal sac is a potential source of intraocular infection, which can easily lead to 
endophthalmitis during intraocular surgery or ocular trauma. At present, there are many measures 
to treat chronic dacryocystitis, the treatment principle is to dredge or re-establish the nasal drainage 
channel, eliminate obstruction, and inhibit infection. At present, the main treatment methods are 
external dacryocystorhinostomy, nasolacrimal duct intubation, lacrimal passage laser plasty and 
endoscopic dacryocystorhinostomy. After evolution and improvement, the operation success rate 
has increased to more than 90%, but there are still shortcomings such as facial skin scar, surgical 
trauma, damage to the "tear pump" function, and inability to treat nasal diseases at the same time. 
Nasolacrimal duct intubation and lacrimal passage laser plasty have the advantages of simple 
operation, time-saving, easy tolerance and repeatable operation. However, since they are not 
operated under direct vision, they are easy to form false passages, and easy to cause adhesion and 
scar formation between the lacrimal passage mucous membranes. The long-term efficacy is still 
controversial. 
With the development of nasal endoscopy technology and the improvement of patients' 
requirements for facial aesthetics, dacryocystorhinostomy under nasal endoscopy has gradually 
become the main surgical method for the treatment of chronic dacryocystitis. Compared with 
traditional external dacryocystorhinostomy, dacryocystorhinostomy under nasal endoscope has the 
advantages of "tear pump" function without damage to inner canthus ligament and deep branch of 
orbicularis oculi muscle. It also causes no facial scar left, and can simultaneously treat the nasal 
complications. The operation is under high-definition magnification endoscopic vision, so that it’s 
also a fine, simple and minimally invasive surgery. With the widespread promotion of its clinical 
application, it has gradually been found that the granulation or scar formation at the anastomosis 
after endoscopic dacryocystorhinostomy is the main reason for the failure of the operation. How to 
achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid 
the proliferation of granulation and cicatricial adhesion is very important for the success of 

the operation. In order to improve the success rate of operation, many explorations have been made, 
such as suture between lacrimal sac flap and nasal mucoperiosteal flap during operation. In order to 
maintain the patency of the anastomosis, artificial lacrimal duct, mitomycin C and lacrimal duct 
dilator stent have all been applied to the anastomosis, but they all have certain disadvantages. For 
example, artificial lacrimal duct and dilator stent are easy to fall off and become blocked again, and 
need to be removed by a second operation, which is often accompanied by bleeding and can affect 
wound healing. Mitomycin C has certain toxic and side effects. Though it can reduce scar 
hyperplasia, it can also delay anastomotic wound healing and epithelialization. 
In recent years, with the wide application of new technologies and new materials, the medical 
community and the medical polymer material community have reached a consensus that hydrogels 
will become a powerful tool to solve the problem of clinical wound repair and tissue flap adhesion. 
Hydrogel has the most similar structure and mechanical properties of human soft tissue, which can 
provide a good self-healing environment. Secondly, hydrogel can form an effective physical barrier, 
which can quickly stop bleeding, close the wound, and effectively reduce the incidence of adhesion 
and infection. More importantly, hydrogel has the function of drug carrier and cell scaffold, which 
can carry drugs, cytokines and even stem cells. These can effectively promote wound repair and 
healing. Therefore, the conversion of hydrogel materials into clinical products is one of the most 
important goals in this field. Similar to the photosensitive dental repair technology, photosensitive 
hydrogels can achieve in situ modeling of irregular wounds with excellent controllability. A single 
component is particularly easy to clinical operation, which is an important development direction 
of hydrogels medical materials. However, the current technology has an important defect due to its 
inability to adhere firmly to and integrate with wet tissues. 
Photosensitive hydrogel products will realize the innovation of hydrophilic polymer in situ 
crosslinking forming on the wound surface. It can be adapted to any irregular wound, and the 
"photocoupling reaction" technology can achieve seamless integration and strong adhesion of 
hydrogel material and wound. Therefore, the photosensitive hydrogel products have the following 
advantages: (1) Excellent adhesion ability, which can realize the close adhesion and hemostasis of 
irregularly shaped tissue wounds, reduce wound exposure, reduce infection risk, and take into 
account the analgesic function; (2) The hydrogel is used as the skeleton of biological 
macromolecules, and the crosslinking process is mild and controllable, with excellent biosafety and 

biodegradability; (3) The hydrogel is soft and elastic, with a high degree of mechanical strength 
consistent with human soft tissue. 
The photosensitive hydrogel uses the natural human component, hyaluronic acid, as the 
biological macromolecule skeleton. After packaging, it has undergone strict medical grade 
sterilization treatment, which meets the national GB/T 16886 standard. It is non-toxic to the human 
body, has no allergy and rejection reaction, and ensures the biosafety to the maximum extent (see 
the attachment for details). Approved by the Ethics Committee of Changhai Hospital Affiliated to 
Naval Medical University (see attachment for a copy of the ethics approval), clinical trials of suture-
free skin trauma and chronic wound repair of more than 200 cases (including children) have been 
completed in its burn department since 2018, and no adverse reactions have been reported. At the 
same time, Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai 
University of Traditional Chinese Medicine, the Second Affiliated Hospital of Wenzhou Medical 
University and Ningbo Huami Hospital of University of Chinese Academy of Sciences respectively 
conducted clinical application research on postoperative wound treatment using the hydrogel, 
including hepatoenteropathy, prevention and treatment of pediatric prepuce adhesion, and treatment 
of skin donor area wounds (copy of the ethical approval letter is attached). 
Therefore, based on the clinical application value of photosensitive hydrogel, this study applied 
it to the suture-free adhesion of lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic 
dacryocystorhinostomy. In order to achieve wound closure and promote wound healing, it can 
prevent postoperative anastomotic adhesion and granulation, replace the need for suture of mucosal 
flap, and greatly shorten the operation time. 
2、Research purpose 
To study the effect of photosensitive hydrogel used for suture-free anastomosis of lacrimal cyst 
and nasal mucoperiosteal flap in endoscopic nasal dacryocystorhinostomy. To evaluate its ability to 
promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and 
shortening operation time. 
3、Type of study design, randomized grouping method and blind level 
This study was a single-blind, prospective, parallel controlled, single-center clinical study, 
randomized by random number method. 
4、Subject inclusion criteria, exclusion criteria, discontinuation criteria 

4.1Study case inclusion criteria 
1) Voluntarily participate in this clinical study and sign the informed consent; 
2) Gender is not limited, age 18-75 years old; 
3) The patient had symptoms and signs of chronic dacryocystitis, and the results of lacrimal 
passage irrigation suggested that the lower rush and return or upper rush and lower return, 
accompanied by mucous or purulent discharge reflux; 
4) CT dacryocystography suggests nasolacrimal duct obstruction without lacrimal canaliculi 
and/or duct obstruction. 
4.2Exclusion criteria 
1) Age < 18 or > 75 years old; 
2) Previous history of dacryocystorhinostomy; 
3) Abnormal coagulation function; 
4) Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors; 
5) in the acute dacryocystitis attack stage; 
6) obvious scar constitution; 
7) Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic 
rhinosinusitis and nasal polyps, acute suppurative rhinosinusitis, severe atrophic rhinitis, and severe 
deviation of nasal septum; 
8) Have serious heart, liver, kidney, lung and other basic diseases, cannot tolerate general 
anesthesia; 
9) Distance from the hospital, postoperative review is not convenient; 
10) Participated in other clinical trials within the last 3 months; 
11) Any medical history that the investigator determines may interfere with the test results or 
increase the patient's risk. 
4.3Termination and exit criteria 
(1) Observation of the influence of other diseases during treatment; 
(2) Poor compliance, cannot strictly implement the program, failed to treat according to 
regulations; 
(3) Drugs that may affect the observation of the study need to be used in combination during 
the trial; 

(4) Lost follow-up; 
(5) The research object asks to quit; 
(6) Serious adverse events; 
(7) The researcher considers it necessary for the subjects to terminate this study. 
5、Research method 
5.1 Subject selection: This was a single-center, randomized, parallel controlled clinical trial 
to evaluate the efficacy and safety of endoscopic dacryocystorhinostomy using suture and 
photosensitive hydrogel. The study plan included 20 subjects, all of whom were randomly assigned 
1:1 to either the suture group or the photosensitive hydrogel group. 
5.2 Preoperative evaluation 
All patients underwent slit lamp, fundus and other ophthalmic examinations to exclude 
ophthalmic diseases, especially ocular surface diseases. The lacrimal duct was syringed to remove 
the stenosis or obstruction of lacrimal canaliculi or common duct. Endoscopic examination was 
performed to understand the nasal condition and observe whether there was obvious middle nasal 
passage stenosis, nasal septum deviation and nasal mucosal lesions. CT dacryocystography was 
performed to observe and measure the size of lacrimal sac, to understand the obstruction of 
nasolacrimal duct, and to determine the incision location. General examination such as chest film, 
electrocardiogram, biochemistry and coagulation were performed to rule out systemic lesions 
5.3 Endoscopic dacryocystorhinostomy 
The patient was placed in supine position under general anesthesia, and was routinely 
disinfected and laid down. Epinephrine injection 1ml was mixed with 2% lidocaine injection 20ml. 
The nasal mucosa was contracted with cotton pads impregnated with the mixture, and the nasal 
submucosal infiltration was performed on the anterior uncinate process in the anterior axillary of 
the middle turbinate. Under the direct vision of 0-degree ultra-wide angle endoscope, a nasal mucosa 
incision of about 1.0cm×0.8cm was made in the anterior axillary part of the middle turbinate parallel 
to the uncinate process to form a nasal mucosa flap, which separated the nasal mucosa and pushed 
it to the rear, covered with cotton sheets for protection, exposed the bone, and visible lacrimal-
maxillary suture. The bone was thined by dynamic system, and the bone was removed by bone 
biting forceps. A bone window about 1.0cm×1.2cm in size was formed to expose the lacrimal sac 
and trim the edge of the bone window to make it smooth. The probe was introduced into the lacrimal 

sac through the upper lacrimal dot and lacrimal canaliculi and lifted up the inner wall of the lacrimal 
sac. The puncture bayonet was gently bent about 30 degrees to cut the lacrimal sac, and the lacrimal 
passage was rinsed to observe whether liquid flowed from the lacrimal sac incision, so as to confirm 
whether the lacrimal sac wall was cut. The pedicled nasal mucoperiosteal flap was pruned and 
covered in the surrounding bone window, respectively. The lacrimal sac mucoperiosteal flap was 
anastomosed with the nasal mucoperiosteal flap. The experimental group and the control group were 
divided into two groups for mucoperiosteal anastomosis intervention. 
5.4 Research groups: 
A、Trial group: 10 patients were expected to be included. The lacrimal cyst mucosal flap 
and nasal mucoperiosteum flap were anastomosed with photosensitive hydrogel. Appropriate 
amount of photosensitive hydrogel was applied on the surface of the trimmed and flat mucosal 
valve, which was irradiated by a light source of 395 nm for about 15 s to solidify and bond. 
B、Control group: 10 patients are expected to be included. The lacrimal membrane flap 
and nasal mucoperiosteal flap were anastomosed by suture method, and the 6-0 absorbable 
thread was used to suture 2 stitches. 
5.5 Postoperative follow-up: All subjects were required to have four outpatient follow-up 
visits (2 weeks, 6 weeks, and 12 weeks). The following indicators should be observed at each 
follow-up visit: 
1) Whether the postoperative symptoms of tears and pus disappeared; 
2) Whether the tear duct is unobstructed; 
3) The anastomosis was well opened and there was no granulation or scar formation under 
endoscope. 
The main evaluation index of this study was that the opening of the anastomosis was observed 
by nasal endoscopy at 6 weeks. The secondary outcome measures were the remission of tearing 
symptoms assessed by VAS scale at 2, 6, and 12 weeks. 
Safety evaluation indicators: anastomotic scar, granulation, wound infection, allergic reaction, 
eye slit-lamp examination and vision examination. 
6、Implementation steps and test flow chart 

 
 
The following table is the test flow table: 
Item 
pre-operation 
postoperation 
2 weeks 
6 weeks 
12 weeks 
Cases were identified for 
inclusion/exclusion 
√ 
 
 
 
Sign informed consent 
√ 
 
 
 
General information 
√ 
 
 
 
Medical history and treatment history 
√ 
 
 
 
Concomitant disease 
√ 
 
 
 
Signs and symptoms 
√ 
√ 
√ 
√ 
Vision 
√ 
√ 
√ 
√ 
Slit-lamp examination 
√ 
√ 
√ 
√ 
Lacrimal duct irrigation 
√ 
 
√ 
√ 
CT Dacryocystography 
√ 
 
 
 
Nasal endoscopy 
√ 
√ 
√ 
√ 
Anastomotic opening state 
 
√ 
√ 
√ 

 
7、Research risk 
The photosensitive wound sealing hydrogel uses hyaluronic acid, a natural component of 
human body, as the biological macromolecule skeleton. It is strictly sterilized after packaging, which 
has excellent biosafety. At present, the safety evaluation has been completed by a third party 
institution, and it is non-toxic to the human body, no allergy and rejection reaction, and the 
maximum degree of biosafety is guaranteed. As an exogenous implant, the risk of adverse reactions 
cannot be ruled out, including various unforeseen infections and related complications such as 
allergies that may occur after use. The study will focus on monitoring and follow-up observation. 
Any unexpected adverse event occurring during the clinical trial will be reported to the principal 
investigator of the clinical research unit and the ethics committee within 24 hours, and the adverse 
event record form (see attached case report form) will be filled in to record the occurrence time, 
severity, duration, measures taken and outcome of the adverse event. All adverse events will be 
treated as usual immediately after occurrence and followed up until symptoms or signs and 
corresponding physical and chemical examination return to normal or stable disease. 
 
8、Adverse event determination 
An adverse event (AE) is any adverse medical condition that occurs after a clinical trial subject 
receives treatment that is not necessarily causally related to the treatment. Dry eye symptoms are 
generally not recorded as AE, and are considered adverse events unless the severity of dry eye 
symptoms exceeds that prior to trial participation. This situation needs to be judged by both the 
subject and the researcher. 
Adverse events include symptoms or signs observed by the investigator or voluntarily reported 
by the subject. The record of adverse events should include: event nature, start time, end time, event 
intensity, relationship with the investigational drug, expectation, action taken, severity, and outcome. 
Adverse events (both investigator-asked and observed and subject actively reported) will be 
Scar condition of anastomosis 
 
√ 
√ 
√ 
Granulation condition of anastomosis 
 
√ 
√ 
√ 
Adverse reaction evaluation 
 
√ 
√ 
√ 

monitored throughout the trial. All adverse events will be reviewed for accuracy and completeness 
by the investigator in a timely manner. Severity and evaluation criteria of adverse events 
Mild: The event is noticeable to the subject, but easily tolerated and does not interfere with the 
subject's daily activities. 
  Moderate: The event caused some distress to the subject, may require other treatment, and may 
affect the subject's daily activities. 
Severe: The event is intolerable, requires additional treatment or changes in previous treatment, 
and significantly affects the subject's daily activities. 
AE Outcome: The outcome of any adverse event will be determined and recorded using the 
following categories: 
Recovered/relieved. 
Recovering/in remission. 
No recovery/no remission. 
Recovered/in remission but with sequelae. 
Loss of follow-up. 
A threat to life or death. 
Unknown. 
Serious adverse events (SAEs) must be handled in a timely manner in accordance with relevant 
regulations, and any of the following cases are considered SAE. 
Cause death. 
Is dangerous to life and capable of causing permanent or significant disability. 
Permanent damage to organ function. 
Resulting in hospitalization or prolonged hospital stay. 
Carcinogenic, teratogenic and birth defect. 
9、Data management, data preservation 
The case report form and research data are uniformly managed by the full-time data manager, 
and the database is established. At the same time, keep all research data, including original hospital 
records, informed consent forms, case reports, research records, etc. The retention period is 5 years. 
10、Researcher Statement and ethical requirements 
The principal investigator has received the national GCP training and obtained the certificate. 

This clinical study was conducted in accordance with the Declaration of Helsinki and in accordance 
with national GCP and device regulations. Before each patient is enrolled in this study, the research 
physician will give a complete and comprehensive introduction to the purpose, procedure and 
possible risks of this study, and the subjects will give their consent after full understanding and sign 
the "informed consent" before starting the clinical trial. At the same time, if there are problems in 
the actual implementation of the clinical trial, this plan needs to be revised. The revised test plan is 
again submitted to the Ethics Committee for approval before implementation. 
 
 

 
 
 
 
 
 
 
 
 
Case Report Form 
 
 
Participant name：                                
Number：                                
Study start date：   20|__|__|/|__|__|/|__|__| 
Study end date：   20|__|__|/|__|__|/|__|__| 
 Signature：                                 
 
 
 

Instructions for filling out the case report 
form 
1.  All subjects who signed the informed consent are required to fill in the case report form. 
2.  The case report form must be filled in accurately and clearly, and shall not be altered 
at will. The error should be corrected with a horizontal line in the center, and sign the 
name of the modifier and the time of modification. Do not cover up the original data 
filled in, do not use erasers, correction fluid to cover or draw many lines. Example:58.6  
58.4 LXD  2011/10/29 
3. All items on each page of CRF should be filled in. For all selected items, enter“×”in“□”to 
indicate this item, for example: ×. If this item is "not done", enter "ND". For "Don't know", 
enter "UK". For "not available" or "not applicable", fill in "NA". 
4. The dates on all forms are in the "Year/month/day" format, including the subject's date 
of birth. If you do not know the specific date, please use "UK" and enter the date in the 
form of "year/month /UK", please fill in as complete a date as possible. The clock is 24 
hours. 
5. Reporting of serious adverse events: If any serious adverse events occur during 
treatment, regardless of whether they are related to this study, the investigator shall 
immediately report them to the head of the study, who shall immediately report them to 
the research unit. 
Emergency contact: 
Research unit: Eye, Ear, Nose and Throat Hospital of Fudan University 
  Contact person：Lin Tong    Contact number：13585764906 
 
 
 
 

Clinical trial process： 
 
 
 
 
 
Item 
pre-
operation 
postoperation 
2 
weeks 
6 
weeks 
12 
weeks 
Cases were identified for 
inclusion/exclusion 
√ 
 
 
 
Sign informed consent 
√ 
 
 
 
General information 
√ 
 
 
 
Medical history and treatment history 
√ 
 
 
 
Concomitant disease 
√ 
 
 
 
Signs and symptoms 
√ 
√ 
√ 
√ 
Vision 
√ 
√ 
√ 
√ 
Slit-lamp examination 
√ 
√ 
√ 
√ 
Lacrimal duct irrigation 
√ 
 
√ 
√ 
CT Dacryocystography 
√ 
 
 
 
Nasal endoscopy 
√ 
√ 
√ 
√ 
Anastomotic opening state 
 
√ 
√ 
√ 
Scar condition of anastomosis 
 
√ 
√ 
√ 
Granulation condition of anastomosis 
 
√ 
√ 
√ 
Adverse reaction evaluation 
 
√ 
√ 
√ 

Inclusion criteria： 
 
Content 
Yes No 
1 
Volunteer to participate in this clinical study and sign 
informed consent 
 
 
2 
No gender limitation, age 18-75 years old 
 
 
3 
The patient had symptoms and signs of chronic 
dacryocystitis, and the results of lacrimal passage irrigation 
suggested that the lower rush and return or upper rush and 
lower return, accompanied by mucous or purulent discharge 
reflux 
 
 
4 
Dacryocystography suggests nasolacrimal duct obstruction 
without lacrimal canaliculi and/or duct obstruction 
 
 
Exclusion criteria： 
ID 
Content 
Yes 
No 
1 
Age < 18 or > 75 years old 
 
 
2 
Previous history of dacryocystorhinostomy 
 
 
3 
Abnormal coagulation function 
 
 
4 
Tumors of lacrimal passage, especially papilloma or 
malignancy 
 
 
5 
Acute dacryocystitis 
 
 
6 
Obvious cicatricial constitution 
 
 
7 
Complicated with severe nasal diseases, such as severe 
allergic rhinitis, chronic rhinosinusitis and nasal polyps, 
acute suppurative rhinosinusitis, etc. 
 
 
8 
Have serious heart, liver, kidney, lung dysfunction and 
other basic diseases, cannot tolerate general anesthesia; 
 
 
9 
Those who are not willing to review regularly after surgery;  
 
10 
Participated in other clinical trials within the last 3 months  
 
11 
Any medical history that the investigator determines may 
interfere with the test results or increase the patient's risk 
 
 
Note: If any of the inclusion criteria is "No" and any of the exclusion criteria is "Yes", the 
case cannot be included in the group. 

Basic patient information: 
Date of birth：          Gender：□ female／□ male      Race:         
Vital sign：Blood pressure：    ／    mmHg    Heart rate：    times/min 
History of present illness： 
Symptom:                         Sign：                     
Drug allergy history： 
Drug allergy： □No   □Yes，please describe：                                       
Past medical history： 
Whether you have a past medical history：□ Yes  □ No 
Name of disease 
Existence or 
not 
Name of disease 
Existence or not 
 
□ Yes □ No 
 
□ Yes □ No 
 
□ Yes □ No 
 
□ Yes □ No 
 
□ Yes □ No 
 
□ Yes □ No 
Join a group 
Does the subject meet all the 
above criteria and be formally 
enrolled? 
□ No→Exit test→Keep research records 
□Yes→The patients were enrolled into observational 
clinical study 
Confirm the enrollment time 20|_|_|Year|_|_|Month|_|_|Day。 
 
Objective 
examination 
record 
form 
before 
operation 
after 
enrollment:            
|_|_|_|_|Year|_|_|Month|_|_|Day 
Check item 
Result 
sight 
 
Slit-lamp examination 
 
Lacrimal duct irrigation 
 
CT Dacryocystography 
 
Nasal endoscopy 
 
 
Surgical record 

Preoperative diagnosis：                          
Intraoperative diagnosis：                          
Name of operation：                          
Process record：                                                         
                                                               
                                                            
                                                            
                                                            
                                                             
                                    
 
 
 
 
  Surgeon's signature： 
|_|_|_|_|Year|_|_|Month|_|_|Day 
 
 
 
 
 
 
 

Postoperative follow-up： 
Name 
 
Date of visit 
□□□□/□□/□□ 
interview1 
Week □ 
Vision：OD           OS         
Slit-lamp microscopy： 
Check item 
Right eye 
Inspection result 
Left eye 
Inspection result 
Eyelids 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
conjunctiva 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
cornea 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
iris 
□Normal 
□Abnormal： 
□Normal 
□Abnormal： 
Anterior 
chamber 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
lens 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
Degree of symptom improvement：                     
Lacrimal duct irrigation：OD                    OS        
Nasal endoscopy： 
Whether the anastomosis is open     □Yes  □No 
Whether there is scar with adhesion   □Yes  □No 
Whether there is granulation          □Yes  □No 
 
 

Postoperative follow-up： 
Name 
 
Date of visit 
□□□□/□□/□□ 
Interview2 
Week □ 
Vision：OD           OS         
Slit-lamp microscopy： 
Check item 
Right eye 
Inspection result 
Left eye 
Inspection result 
Eyelids 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
conjunctiva 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
cornea 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
iris 
□Normal 
□Abnormal： 
□Normal 
□Abnormal： 
Anterior 
chamber 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
lens 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
Degree of symptom improvement：                     
Lacrimal duct irrigation：OD                    OS        
Nasal endoscopy： 
Whether the anastomosis is open     □Yes  □No 
Whether there is scar with adhesion   □Yes  □No 
Whether there is granulation          □Yes  □No 
 
 

Postoperative follow-up： 
Name 
 
Date of visit 
□□□□/□□/□□ 
Interview3 
Week □ 
Vision：OD           OS         
Slit-lamp microscopy： 
Check item 
Right eye 
Inspection result 
Left eye 
Inspection result 
Eyelids 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
conjunctiva 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
cornea 
□Normal  
□Abnormal： 
□Normal 
□Abnormal： 
iris 
□Normal 
□Abnormal： 
□Normal 
□Abnormal： 
Anterior 
chamber 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
lens 
□Normal  
□Abnormal： 
□Normal  
□Abnormal： 
Degree of symptom improvement：                     
Lacrimal duct irrigation：OD                    OS        
Nasal endoscopy： 
Whether the anastomosis is open     □Yes  □No 
Whether there is scar with adhesion   □Yes  □No 
Whether there is granulation          □Yes  □No  
 
 

Adverse event report form 
Are adverse events occurring? □ No □ Yes, if yes, please fill in the following form: 
Name of adverse event 
 
 
Clinical diagnosis 
 
 
Date and time of 
occurrence 
|_|_|_|_|Year|_|_|month|_|_|day 
|_|_|hour|_|_|minute（24-hour system） 
|_|_|_|_|Year|_|_|month|_|_|day 
|_|_|hour|_|_|minute（24-hour system） 
Severity  
□1Light    □2Medium    □3Heavy 
□1Light    □2Medium    □3Heavy 
Adverse event 
characteristics 
□paroxysmal（Number of attacks：|_|_|）
□persistence  
□other                  
□paroxysmal（Number of attacks：|_|_|） 
□persistence  
□other                  
Course of adverse events 
(including symptoms and 
signs) 
 
 
 
Adverse event processing 
(including the generic 
name, dosage, usage and 
other therapeutic 
measures of the drug 
used) 
□No  □Yes, if yes, record it 
                                    
                                    
                                    
                                    
                                    
                                    
□No  □Yes, if yes, record it 
                                    
                                    
                                    
                                    
                                    
                                    
Fill in the following sections at the end of the adverse event or follow-up 
Follow-up time 
Time：|_|_|_|_|Year|_|_|month|_|_|day 
|_|_|hour|_|_|minute
（
24-hour
system） 
Time：|_|_|_|_|Year|_|_|month|_|_|day 
|_|_|hour|_|_|minute （24-hour
system） 
Outcome of adverse 
events 
□1Disappear/return to normal  
□2 Turn for the better 
□3 No better           
□4 There are sequelae, manifestations：  
□1Disappear/return to normal  
□2 Turn for the better 
□3 No better           
□4 There are sequelae, manifestations：
Whether to quit the trial 
□ No    □ Yes     
□ No    □ Yes     
Note: * : Severity rating: 
1. Light: the subject can tolerate, does not require special treatment, and has no impact on the health 
of the subject. 
2. Medium: unbearable for subjects, which has a direct impact on subjects' health. 
3. Heavy: endangering the life of the subject, causing death or disability, requiring urgent treatment. 
 
 
 

 
 
 
 
 
 
 
 
 Summary of the completion of the test 
Have you completed this clinical trial? 
□Yes  □No, if no, please fill in the following items: 
Trial exit date ：|_|_|_|_|Year|_|_|Month|_|_|Day 
The main reasons for quitting the trial were: 
□1 Loss to follow-up 
□2 Adverse event 
□3 Subject automatically withdrew from the test for:                              
□4 The investigator decided to withdraw the subjects from the trial for the following reasons:  
□5 Other                          
Did the patient experience any adverse events during the trial?           
□Yes     □No 
If there were adverse events, have they all been resolved?   
□Yes     □No 
If no, follow up to normal or pre-medication levels. 
Is this a qualified case? □ Yes □ no. If no, please fill in the following items: 
□1 Violation of inclusion criteria 
□2 Drop-out test 
□3 Poor compliance 
□4 Other             
 
 
 
 
 

 
 
   
 
Principal investigator signature：                       
Date：      Year   Month    Day 
 
 
 
 
 
 
 
 
Case Report Form (CRF) review statement 
 
As the person in charge of the test center, I hereby declare: 
After review, the records of all items in this case report form 
are true, complete and accurate.