Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.

Sponsor
Khon Kaen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04726267
Collaborator
(none)
46
1
1
36
1.3

Study Details

Study Description

Brief Summary

Intraocular surgery could induce vitreous degeneration and posterior vitreous detachment (PVD). Vitreomacular interface (VMI) abnormalities usually are caused by abnormal PVD, vitreoschisis and partial-thickness PVD. Furthermore, the PVD could induce the peripheral break. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%.

The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.

Condition or Disease Intervention/Treatment Phase
  • Device: Wide-field optical coherence tomography
N/A

Detailed Description

Trabeculectomy is one of the intraocular surgery. Although the volume of intraocular fluid use during the trabeculectomy was much less than used during phacoemulsification, trabeculectomy also could induce the PVD and it's sequelae such as VMI abnormalities. Because the baseline visual acuity of glaucoma patients who were indicated for trabeculectomy usually quite poor, so the sequelae of PVD can cause more visual loss. The incidence of PVD after trabeculectomy has never been published before and nowadays no standard guideline for retinal examination or screening after surgery. Furthermore, Tsukahara et al introduced wide-field OCT-based PVD classification. The new OCT device with higher technology will be useful in PVD detection.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Glaucoma patients who was scheduled for trabeculectomy

Wide-field OCT was performed 1-2 weeks before the trabeculectomy. The OCT was done postoperatively at 1 month, 3 months, 6 months and 12 months after surgery.

Device: Wide-field optical coherence tomography
Merged 4 images of wide-field optical coherence tomography, 2 images of vertical scan and 2 images of horizontal scan.

Outcome Measures

Primary Outcome Measures

  1. Incidence of PVD [12 months]

    complete PVD

Secondary Outcome Measures

  1. The incidence of VMI abnormalities [12 months]

    Vitreomacular traction, Epimacular membrane, Peripheral retinal break

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Primary open angle glaucoma or primary angle closure glaucoma

  • Age 18-65 years

  • Could be taken the wide-field OCT images

  • Written informed consent

Exclusion Criteria:
  • History of intraocular inflammation or infection

  • History of ocular trauma or head trauma

  • History of intraocular surgery such as intravitreal drug injection and cataract surgery

  • History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration

  • History of laser treatment including laser capsulotomy and retinal photocoagulation

  • High myopia; spherical equivalence >4 diopters

  • Complete PVD was detected before the enrollment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Khon Kaen University Khon Kaen Thailand 40002

Sponsors and Collaborators

  • Khon Kaen University

Investigators

  • Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suthasinee Sinawat, KKU Eye Center, Department of Ophthalmology, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT04726267
Other Study ID Numbers:
  • HE631456
First Posted:
Jan 27, 2021
Last Update Posted:
Jun 30, 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 Suthasinee Sinawat, KKU Eye Center, Department of Ophthalmology, Khon Kaen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021