Clinical trial NCT04957459: The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
Official title: Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Holes
Keywords: idiopathic full thickness macular hole
OCTA
postoperative best corrected visual acuity
vitrectomy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic macular hole after vitrectomy combined with internal limiting membrane peeling and air-filling surgery and the MH is closed and the postoperative best corrected visual acuity is at least 1 month

Brief summary: This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.

Detailed description: After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.

Eligibility criteria: Inclusion Criteria:

* idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.

Exclusion Criteria:

* High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, \>21 mm Hg) or glaucoma, severe cataract, severe corneal disease，severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery

Primary outcomes:
measure: Macular hole status
timeFrame: at 1 month after surgery
measure: MLD of macular hole
timeFrame: Before surgery
measure: BD of macular hole
timeFrame: Before surgery
measure: Choroidal hypertransmission width of macular hole
timeFrame: Before surgery
measure: Horizontal ellipsoid band missing diameter of macular hole
timeFrame: Before surgery
measure: Baseline best-corrected visual acuity
timeFrame: Before surgery
measure: best-corrected visual acuity at 1 month
timeFrame: at 1 month after surgery
measure: best-corrected visual acuity at 2 months
timeFrame: at 2 months after surgery
measure: best-corrected visual acuity at 3 months
timeFrame: at 3 months after surgery
measure: best-corrected visual acuity at 4 months
timeFrame: at 4 months after surgery
measure: best-corrected visual acuity at 5 months
timeFrame: at 5 months after surgery
measure: best-corrected visual acuity at 6 months
timeFrame: at 6 months after surgery
measure: FAZ area of macular hole
timeFrame: Before surgery
measure: FAZ area of macular hole at 1 month
timeFrame: at 1 month after surgery
measure: FAZ area of macular hole at 2 months
timeFrame: at 2 months after surgery
measure: FAZ area of macular hole at 3 months
timeFrame: at 3 months after surgery
measure: FAZ area of macular hole at 4 months
timeFrame: at 4 months after surgery
measure: FAZ area of macular hole at 5 months
timeFrame: at 5 months after surgery
measure: FAZ area of macular hole at 6 months
timeFrame: at 6 months after surgery
measure: CRT of macular hole
timeFrame: Before surgery
measure: CRT of macular hole at 1 month
timeFrame: at 1 month after surgery
measure: CRT of macular hole at 2 months
timeFrame: at 2 months after surgery
measure: CRT of macular hole at 3 months
timeFrame: at 3 months after surgery
measure: CRT of macular hole at 4 months
timeFrame: at 4 months after surgery
measure: CRT of macular hole at 5 months
timeFrame: at 5 months after surgery
measure: CRT of macular hole at 6 months
timeFrame: at 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Qi Wan
role: PRINCIPAL_INVESTIGATOR
References: