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

Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Zhiyong Zhang, docter; Phone Number: 13968059392; Email: zhangziyongnet@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Zhiyong Zhang, docter; Phone Number: 13968059392; Email: zhangziyongnet@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular hole status	macular hole status (open, flat open or closed)	at 1 month after surgery
MLD of macular hole	Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography	Before surgery
BD of macular hole	Calculation of base diameter of macular hole with optical coherence tomography angiography	Before surgery
Choroidal hypertransmission width of macular hole	Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography	Before surgery
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
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
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
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
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
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
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
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
FAZ area of macular hole	Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography	Before surgery
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
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
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
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
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
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
CRT of macular hole	Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography	Before surgery
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Qi Wan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: OCTA; vitrectomy; idiopathic full thickness macular hole; postoperative best corrected visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: I2021001380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No