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

NCT04957459 | Unknown

• 1 other identifier: I2021001380
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

idiopathic full thickness macular hole; OCTA; postoperative best corrected visual acuity; vitrectomy

Outcome Measures

Primary Outcomes (26)

• 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

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Qi Wan

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Zhang, docter

CONTACT

13968059392; zhangziyongnet@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 12, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: July 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)