The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes

• Conditions: Macular Holes

• Registration Number: NCT04957459
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FAZ area of macular hole at 5 months	at 5 months after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
CRT of macular hole	Before surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
MLD of macular hole	Before surgery	Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography
best-corrected visual acuity at 4 months	at 4 months after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
CRT of macular hole at 4 months	at 4 months after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Macular hole status	at 1 month after surgery	macular hole status (open, flat open or closed)
Horizontal ellipsoid band missing diameter of macular hole	Before surgery	Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography
best-corrected visual acuity at 3 months	at 3 months after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 5 months	at 5 months after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
FAZ area of macular hole at 4 months	at 4 months after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
CRT of macular hole at 5 months	at 5 months after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
best-corrected visual acuity at 6 months	at 6 months after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
FAZ area of macular hole at 1 month	at 1 month after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 6 months	at 6 months after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
CRT of macular hole at 1 month	at 1 month after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Choroidal hypertransmission width of macular hole	Before surgery	Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography
Baseline best-corrected visual acuity	Before surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 1 month	at 1 month after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
FAZ area of macular hole	Before surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
BD of macular hole	Before surgery	Calculation of base diameter of macular hole with optical coherence tomography angiography
best-corrected visual acuity at 2 months	at 2 months after surgery	best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
FAZ area of macular hole at 2 months	at 2 months after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 3 months	at 3 months after surgery	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
CRT of macular hole at 2 months	at 2 months after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 3 months	at 3 months after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 6 months	at 6 months after surgery	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

Trial Locations

Locations (1)

Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China