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NCT05790408 · ClinicalTrials.gov registry record · NA

Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR)

A NA study, sponsored by Northwestern University.

Terminated
Registry status
NA
Development phase
10
Enrollment target

NCT05790408: Clinical Trial NA study, sponsored by Northwestern University.

NCT05790408 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05790408, a NA study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

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.

Primary Outcome

Surgical success as defined as a 20% reduction in unmedicated IOP below the pre-operative baseline at specified post-operative visits.

Interventions

  • DEVICE Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG)
  • DEVICE Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-08-18
Est. Completion 2022-01-12
Phase NA
Northwestern University

1,209 total trials

Why NCT05790408 stopped before completion

NCT05790408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) is the first listed.

NCT05790408 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05790408 about?

NCT05790408 is a clinical study titled "Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR)". 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 wel...

What is the current status of trial NCT05790408?

This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2020-08-18. Estimated completion is 2022-01-12.

What interventions are being tested in trial NCT05790408?

The interventions under investigation include: Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) (DEVICE), Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering) (DEVICE).

Who is sponsoring clinical trial NCT05790408?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05790408's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05790408, the US trial registry maintained by the National Library of Medicine. NCT05790408 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.