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

Macular Holes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957459
• Other study ID #: I2021001380
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhiyong Zhang, docter
• Phone: 13968059392
• Email: zhangziyongnet[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole status	macular hole status (open, flat open or closed)	at 1 month after surgery
Primary	MLD of macular hole	Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography	Before surgery
Primary	BD of macular hole	Calculation of base diameter of macular hole with optical coherence tomography angiography	Before surgery
Primary	Choroidal hypertransmission width of macular hole	Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography	Before surgery
Primary	Horizontal ellipsoid band missing diameter of macular hole	Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography	Before surgery
Primary	Baseline best-corrected visual acuity	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	Before surgery
Primary	best-corrected visual acuity at 1 month	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	at 1 month after surgery
Primary	best-corrected visual acuity at 2 months	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	at 2 months after surgery
Primary	best-corrected visual acuity at 3 months	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	at 3 months after surgery
Primary	best-corrected visual acuity at 4 months	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	at 4 months after surgery
Primary	best-corrected visual acuity at 5 months	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	at 5 months after surgery
Primary	best-corrected visual acuity at 6 months	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	at 6 months after surgery
Primary	FAZ area of macular hole	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	Before surgery
Primary	FAZ area of macular hole at 1 month	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 1 month after surgery
Primary	FAZ area of macular hole at 2 months	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 2 months after surgery
Primary	FAZ area of macular hole at 3 months	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 3 months after surgery
Primary	FAZ area of macular hole at 4 months	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 4 months after surgery
Primary	FAZ area of macular hole at 5 months	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 5 months after surgery
Primary	FAZ area of macular hole at 6 months	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	at 6 months after surgery
Primary	CRT of macular hole	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	Before surgery
Primary	CRT of macular hole at 1 month	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 1 month after surgery
Primary	CRT of macular hole at 2 months	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 2 months after surgery
Primary	CRT of macular hole at 3 months	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 3 months after surgery
Primary	CRT of macular hole at 4 months	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 4 months after surgery
Primary	CRT of macular hole at 5 months	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 5 months after surgery
Primary	CRT of macular hole at 6 months	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	at 6 months after surgery