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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04957459
Collaborator
(none)
60
1
25.9
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Outcome Measures

Primary Outcome Measures

  1. Macular hole status [at 1 month after surgery]

    macular hole status (open, flat open or closed)

  2. MLD of macular hole [Before surgery]

    Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography

  3. BD of macular hole [Before surgery]

    Calculation of base diameter of macular hole with optical coherence tomography angiography

  4. Choroidal hypertransmission width of macular hole [Before surgery]

    Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. FAZ area of macular hole [Before surgery]

    Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. CRT of macular hole [Before surgery]

    Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04957459
Other Study ID Numbers:
  • I2021001380
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021