Trial Outcomes & Findings for Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR) (NCT NCT05790408)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Postoperative month 3

Results posted on

2023-11-15

Participant Flow

N/A. Single group, unmasked.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Study Group Subjects scheduled to under trans-conjunctival needle revision
Overall Study STARTED	10 10
Overall Study COMPLETED	7 7
Overall Study NOT COMPLETED	3 3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group Subjects scheduled to under trans-conjunctival needle revision
Overall Study Did not undergo surgery or did not undergo imaging at the time of surgery	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=7 Eyes Eyes scheduled to undergo trans-conjunctival needle revision of trabeculectomy bleb
Age, Continuous	65.4 years n=7 Participants
Sex: Female, Male Female	6 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants
Intraocular pressure (mmHg)	17.65 mm Hg n=7 Eyes

PRIMARY outcome

Timeframe: Postoperative month 3

Population: Subjects who underwent trans-conjunctival needle revision and who underwent intra-operative imaging

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

Outcome measures

Outcome measures
Measure	Study Group n=7 Eyes Subjects who underwent trans-conjunctival needle revision
Surgical Success Success	5 participants
Surgical Success Failure	2 participants

SECONDARY outcome

Timeframe: Intraoperative assessment

Population: All eyes that underwent trans-conjunctival needle revision and intra-operative imaging

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.

Outcome measures

Outcome measures
Measure	Study Group n=7 Eyes Subjects who underwent trans-conjunctival needle revision
Number of Participants With Successful Imaging of the Bleb With iOCT	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-operative visit

Investigators will also assess whether findings seen with pre-operative AS-OCT can predict what type of blebs will benefit from iOCT-assisted TNCR. Features of AS-OCT and iOCT imaging that will be assessed include quality of image capture, visualization of surgical site, and characteristics of the bleb. Characteristics of the surgical site include bleb height, internal reflectivity, location and number of adhesions, and presence of cysts, cavities, and fistulas.

Outcome measures

Outcome data not reported

Adverse Events

Eyes Undergoing Trans-conjunctival Needle Revision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angelo P. Tanna

Northwestern University

Phone: 3129088152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place