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Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR)
NA trial testing Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) in Glaucoma in 10 participants. Terminated before completion.
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 18 August 2020 |
| Primary completion | 12 January 2022 |
| Estimated completion | 12 January 2022 |
| Sites | 1 location across United States |
Northwestern University
18 and older, any sex, with Glaucoma or Glaucoma Following Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Surgical success as defined as a 20% reduction in unmedicated IOP below the pre-operative baseline at specified post-operative visits.
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 2 |
The secondary outcomes will be feasibility of intraoperative OCT. Feasibility will be defined as the percentage of cases with successful imaging of the bleb with iOCT.
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 7 |
Trabeculectomy is a very important and commonly performed glaucoma operation. It allows fluid from inside the eye to exit into a space called a bleb located on the surface of the eye under the upper eyelid. The formation of excessive scar tissue after surgery may cause the operation to work less well or stop working. This results in an increase in eye pressure. The use of a needle to cut the scar tissue is a commonly used procedure. This surgery is called trans-conjunctival needle revision (TCNR) of trabeculectomy bleb. The study aims to determine if advanced optical imaging called Optical Coherence Tomography (OCT) of the scar tissue both in the office prior to surgery and during surgery in the operating room improves the success rate of the revision surgery. These devices are FDA approved and have been used extensively in ophthalmology and ocular surgery. Ophthalmologists already used these imaging devices for this purpose as part of the standard medical care of some patients. The purpose of this study is to prospectively gather information about its use in a systematic way. Furthermore, investigators want to determine if imaging improves outcomes compared to historical controls (patients who underwent the same surgery in the past without imaging). The potential benefit of this research is that it may provide knowledge that will be of benefit to future patients with glaucoma who are undergoing this procedure.
No peer-reviewed publications indexed yet for this trial.
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