Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial

Zheng, Ying; Kang, Mei; Wang, Hong; Liu, Haiyun; Sun, Tao; Sun, Xiaodong; Wang, Fenghua

doi:10.1186/s13063-018-2833-y

Trials

Table 1 General procedure and monitoring process

From: Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial

Period	Screening period	Randomization period	Follow-up period^a
Project	Baseline	Treatment	V1	V2	V3	V4	V5	V6	V7	Termination	Unscheduled visit
Visiting time	–7~0 d	0 d	1 d	1 w	2 w	4 w	8 w	12 w	6 m	12 m	–
Informed consent	×
Inclusion and exclusion criteria	×	×^b
Demographic data	×
Chief complaint and current medical history	×
Medical history	×
Previous surgery/trauma history and ocular surgery history	×
Diagnosis	×
Vital signs^c	×		×	×	×	×	×	×	×	×	×
General physical examination	×		×	×	×	×	×	×	×	×	×
Slit lamp examination^d (binocular)	×
Slit lamp examination^e (study eye)			×	×	×	×	×	×	×	×	×
Electrocardiograph (ECG) and chest radiography^f	×
Laboratory examination^g	×
Auxiliary examinations^h	×		×	×	×	×	×	×	×	×	×
Low Vision Quality-of-Life Questionnaireⁱ	×						×	×	×	×
History change		×
Randomization		×
Surgical treatment		×
Subject files	×
Adverse events^j		×	×	×	×	×	×	×	×	×	×
Previous/combined medication^k	×	×	×	×	×	×	×	×	×	×	×
Quit in advance			×	×	×	×	×	×	×	×
Unscheduled visits											×

Remarks:
V visit, d day, w week, m month, BCVA best corrected visual acuity, INR international standard ratio, OU oculus uterque (both eyes), OCT optical coherence tomography
^aVisit window: visit 2 to visit 6; each visit has a window period of ± 3 days; visit 7 and end visit allow a window period of ± 7 days
^bIf both the eyes meet the requirements in the screening, the eye with the poorer BCVA should be selected as the study eye, unless for medical reasons, the researchers believe that the other eye is more suitable for the research. The study eye will undergo surgical treatment according to the protocol. If the BCVA damage of the contralateral eye is caused by macular hole associated with retinal detachment secondary to high myopia, according to the judgment of the researchers, the contralateral eye can also be recommended for surgical treatment. The contralateral eye is labeled as the contralateral eye for treatment. The treatment of bilateral eyes should not be performed on the same day
^cVital signs, including blood pressure, pulse, respiration, and armpit temperature, should be measured after patient has been sitting for 5 min
^dSlit lamp examination: use “Slit Lamp Examination Form-I” (Additional file 2: Attachment 1). Accept the examination results carried out before the informed consent signature during the same hospitalization
^eSlit lamp examination: use “Slit Lamp Examination Form-II” (Additional file 2: Attachment 2)
^fECG, chest radiography: accept the examination results carried out before the informed consent signature during the same hospitalization
^gLaboratory examination includes routine blood test, blood biochemistry, routine blood coagulation, hepatitis B quantification, hepatitis C virus (HCV) antibody, Treponema pallidum particle agglutination assay (TPPA) plus rapid plasma reagin assay (RPR), and human immune deficiency virus (HIV) antibody. Accept the examination results carried out before the informed consent signature during the same hospitalization
①Routine blood test: white blood cells, neutrophils, lymphocytes, neutrophil ratio, lymphocyte ratio, red blood cells, hemoglobin, platelets
②Blood biochemistry: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, γ-glutamyl transferase, total bilirubin, direct bilirubin, total protein, albumin, urea, creatinine, uric acid, glucose, triglycerides, total cholesterol, potassium, sodium, chloride, calcium, phosphorus
③Routine blood coagulation: prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, prothrombin time-INR
^hAuxiliary examinations:
①Auxiliary examinations in the screening period include BCVA OU, IOP OU, OCT of study eye, wide angle color photo (CP) of study eye, multifocal electroretinogram of study eye, microperimetry and visual field analysis of study eye, ocular axis measurement of study eye, B-scan ultrasonography of study eye. Accept the examination results carried out before the informed consent signature during the same hospitalization
②Auxiliary examinations at V1 and V2 include BCVA OU, IOP OU, OCT of study eye, wide angle CP of study ocular axial measurement of study eye
③ Auxiliary examinations at V3 include BCVA OU, IOP OU, OCT of study eye, wide angle CP of study eye, B-scan ultrasonography of study eye
④Auxiliary examinations at V4 include BCVA OU, IOP OU, OCT of study eye, wide angle CP of study eye
⑤Auxiliary examinations at V5, V6, V7, end visits, and unscheduled visits include BCVA OU, IOP OU, OCT of study eye, wide angle CP of study eye, multifocal electroretinogram of study eye, microperimetry and visual field analysis of study eye, and B-scan ultrasonography of study eye
ⁱThe Low Vision Quality-of-Life Questionnaire: subjects were asked to self-rate according to the Low Vision Quality-of-Life Questionnaire (Additional file 2: Attachment 3)
^jAdverse events (AEs): adverse event information is collected from the time the subjects sign informed consent until the end of the study
^kPrevious/combined medication: collection of relevant information from the time the subjects sign informed consent until the end of the study, including all the medication used for the treatment of AEs or SAEs

Back to article page

ISSN: 1745-6215

Contact us

Submission enquiries: Access here and click Contact Us
General enquiries: info@biomedcentral.com