Supporting Data Capture for a Novel Glaucoma Procedure with Clinion EDC
Overview
In glaucoma device studies, precision is not limited to the procedure itself. It also depends on how clearly each follow-up visit captures the eye’s response after treatment. In this single-site ophthalmology trial, the study team had to record procedure-related safety events, intraocular pressure measurements, inflammatory markers, ultrasound biomicroscopy observations, visual assessments, and patient-reported outcomes across multiple post-procedure timepoints.
The study evaluated a laser-based procedure for adults with primary glaucoma, where treatment response had to be understood through repeated measurements rather than a single endpoint. Each visit added another layer of evidence, making it important to keep procedure data, safety findings, and ophthalmology assessments connected throughout the follow-up period.
Clinion EDC brought control and visibility to the study’s repeated safety and eye-health assessments. With configurable eCRFs, built-in edit checks, centralized query management, and real-time review workflows, the platform helped the sponsor manage follow-up data with greater consistency and less dependence on manual tracking.
Study Snapshot
Industry
Medical Device
Client
Medical device sponsor
Study Type
Interventional
Therapeutic Area
Ophthalmology
Study Phase
Phase II
Study Design
Prospective, randomized, parallel-group, active-controlled medical device study
Randomization
Single blind (outcome assessor blinded)
Region
India
Site Count
1 sites
Submission
DCGI / public registry record
Study Duration
24 months as per project input
Products Provided
Challenges
Managing Complex Glaucoma Follow-Up Data Without Fragmented Review
The study needed every follow-up visit to capture more than routine clinical data. Each visit had to add to a complete patient record, with site-entered findings and patient-reported outcomes kept clear for sponsor review.
01
Making Post-Procedure Safety Data Easier to Review
After the device procedure, the site had to track adverse events, complications, and any need for additional surgery across multiple follow-up visits. The challenge was keeping safety data clearly connected to each patient’s follow-up record, so the sponsor could review it without depending on scattered notes or manual checks.
02
Capturing Patient-Reported Outcomes Alongside Site Data
The study also included patient-reported outcomes, which had to be captured alongside the site’s clinical assessments. The challenge was making sure patient responses were not treated as a separate or secondary record, but stayed connected to the same follow-up flow used for clinical review.
03
Maintaining Data Quality in a Specialist Single-Site Setup
Although the trial was conducted at one specialist ophthalmology site, the data still required close control. The sponsor needed a way to identify missing fields, review unusual entries, raise queries, and keep corrections traceable without adding extra manual coordination for the site team.
Solutions
Unifying Clinical Assessments and Patient-Reported Outcomes Through Clinion EDC
Clinion EDC helped the site capture visit-wise data in a consistent structure, giving the sponsor a clearer view of data completeness and each patient’s follow-up record.
Outcomes
Core Results
Clinion EDC helped the sponsor keep glaucoma study data connected, complete, and easier to review.
Connected Records:
Clinical assessments and patient-reported outcomes stayed linked to the right visit.
Cleaner Capture
Edit checks helped reduce missing or inconsistent entries.
Clearer Review
Centralized queries helped the sponsor track data issues and corrections.
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Compliance
Fully Compliant with Global Standards
