Severe-stage Glaucoma (Mean Deviation ≤ -20 dB)NCT07237555
CVL Risk After Severe Glaucoma Surgery
An observational study of Severe-stage Glaucoma (Mean Deviation ≤ -20 dB), run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This retrospective cohort study analyzes risk factors for central visual loss (CVL) after severe-stage glaucoma surgery. The primary hypothesis is that 1) visual prognosis is determined primarily by early postoperative intraocular pressure (IOP) stability rather than surgical choice, and 2) the nature of risk… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe-stage Glaucoma (Mean Deviation ≤ -20 dB)
- How many people
- 523 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2024to 26 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation at Gangnam Severance Hospital, Yonsei University College of Medicine, between January 2005 and October 2023, with at least 1-year follow-up data available.
Who may be able to join
- 1. Patients who underwent trabeculectomy or Ahmed glaucoma valve implantation at Yonsei Medical Center between January 2005 and October 2024.
- 2. Glaucoma patients who underwent static quantitative perimetry (visual field test) before and after surgery.
- 3. Patients with a preoperative Mean Deviation (MD) of ≤ -20 dB.
Who cannot join
- 1. Patients who were unable to undergo visual field testing due to poor preoperative visual acuity.
- 2. Patients with central visual field defects caused by retinal or neurological diseases other than glaucoma.
- 3. Patients with false-positive or false-negative responses ≥33% on visual field testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Likelihood of Side Effects Between Surgical Methods in Patients With Severe Stage Glaucoma
This retrospective cohort study analyzes risk factors for central visual loss (CVL) after severe-stage glaucoma surgery. The primary hypothesis is that 1) visual prognosis is determined primarily by early postoperative intraocular pressure (IOP) stability rather than surgical choice, and 2) the nature of risk (hypotony vs hypertension) is modified by baseline visual reserve. We analyzed outcomes in 523 patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve (AGV) implantation, focusing on the dichotomous risk profile stratified by baseline visual acuity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 231 eyes that underwent trabeculectomy for severe-stage glaucoma | |
| Group 2 | 292 eyes that underwent Ahmed glaucoma valve implantation for severe-stage glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Visual Loss (CVL) at 3 months postoperatively
Central visual loss defined as any of the following at 3 months postoperatively: (i) best-corrected visual acuity (BCVA) ≤ 20/200; (ii) decrease of ≥ 4 Snellen lines from baseline; or (iii) further deterioration of BCVA in eyes with preoperative BCVA ≤ 20/200.
Measured: At 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start27 Nov 2024
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe-stage Glaucoma (Mean Deviation ≤ -20 dB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wungrak choi, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237555
- Sponsor's protocol ID
- 3-2024-0364
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016/j.ajo.2005.07.044.
PubMed 16386972Bai J, Smock SL, Jackson GR Jr, MacIsaac KD, Huang Y, Mankus C, Oldach J, Roberts B, Ma YL, Klappenbach JA, Crackower MA, Alves SE, Hayden PJ. Phenotypic responses of differentiated asthmatic human airway epithelial cultures to rhinovirus. PLoS One. 2015 Feb 23;10(2):e0118286. doi: 10.1371/journal.pone.0118286. eCollection 2015.
PubMed 25706956Zhu S, Li ZW, Zhao H. Patchy micelles based on coassembly of block copolymer chains and block copolymer brushes on silica particles. Langmuir. 2015 Apr 14;31(14):4129-36. doi: 10.1021/acs.langmuir.5b00526. Epub 2015 Apr 1.
PubMed 25811763Pernas M, Garcia-Casado G, Rojo E, Solano R, Sanchez-Serrano JJ. A protein phosphatase 2A catalytic subunit is a negative regulator of abscisic acid signalling. Plant J. 2007 Sep;51(5):763-78. doi: 10.1111/j.1365-313X.2007.03179.x. Epub 2007 Jul 7.
PubMed 17617176Lambiase A, Micera A, Sacchetti M, Cortes M, Mantelli F, Bonini S. Alterations of tear neuromediators in dry eye disease. Arch Ophthalmol. 2011 Aug;129(8):981-6. doi: 10.1001/archophthalmol.2011.200.
PubMed 21825181
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Likelihood of Side Effects Between Surgical Methods in Patients With Severe Stage Glaucoma
- ClinicalTrials.gov ID
- NCT07237555
- Acronym / sponsor ID
- 3-2024-0364
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective cohort study analyzes risk factors for central visual loss (CVL) after severe-stage glaucoma surgery. The primary hypothesis is that 1) visual prognosis is determined primarily by early postoperative intraocular pressure (IOP) stability rather than surgical choice, and 2) the nature of risk (hypotony vs hypertension) is modified by baseline visual reserve. We analyzed outcomes in 523 patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve (AGV) implantation, focusing on the dichotomous risk profile stratified by baseline visual acuity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –231 eyes that underwent trabeculectomy for severe-stage glaucoma |
| Group 2 | – | –292 eyes that underwent Ahmed glaucoma valve implantation for severe-stage glaucoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation at Gangnam Severance Hospital, Yonsei University College of Medicine, between January 2005 and October 2023, with at least 1-year follow-up data available.
Key inclusion criteria (3 listed)
- 1. Patients who underwent trabeculectomy or Ahmed glaucoma valve implantation at Yonsei Medical Center between January 2005 and October 2024.
- 2. Glaucoma patients who underwent static quantitative perimetry (visual field test) before and after surgery.
- 3. Patients with a preoperative Mean Deviation (MD) of ≤ -20 dB.
Key exclusion criteria (3 listed)
- 1. Patients who were unable to undergo visual field testing due to poor preoperative visual acuity.
- 2. Patients with central visual field defects caused by retinal or neurological diseases other than glaucoma.
- 3. Patients with false-positive or false-negative responses ≥33% on visual field testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Central Visual Loss (CVL) at 3 months postoperatively
Time frame: At 3 months postoperatively
Central visual loss defined as any of the following at 3 months postoperatively: (i) best-corrected visual acuity (BCVA) ≤ 20/200; (ii) decrease of ≥ 4 Snellen lines from baseline; or (iii) further deterioration of BCVA in eyes with preoperative BCVA ≤ 20/200.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 16386972Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016/j.ajo.2005.07.044.
- Background: PubMed 25706956Bai J, Smock SL, Jackson GR Jr, MacIsaac KD, Huang Y, Mankus C, Oldach J, Roberts B, Ma YL, Klappenbach JA, Crackower MA, Alves SE, Hayden PJ. Phenotypic responses of differentiated asthmatic human airway epithelial cultures to rhinovirus. PLoS One. 2015 Feb 23;10(2):e0118286. doi: 10.1371/journal.pone.0118286. eCollection 2015.
- Background: PubMed 25811763Zhu S, Li ZW, Zhao H. Patchy micelles based on coassembly of block copolymer chains and block copolymer brushes on silica particles. Langmuir. 2015 Apr 14;31(14):4129-36. doi: 10.1021/acs.langmuir.5b00526. Epub 2015 Apr 1.
- Background: PubMed 17617176Pernas M, Garcia-Casado G, Rojo E, Solano R, Sanchez-Serrano JJ. A protein phosphatase 2A catalytic subunit is a negative regulator of abscisic acid signalling. Plant J. 2007 Sep;51(5):763-78. doi: 10.1111/j.1365-313X.2007.03179.x. Epub 2007 Jul 7.
- Background: PubMed 21825181Lambiase A, Micera A, Sacchetti M, Cortes M, Mantelli F, Bonini S. Alterations of tear neuromediators in dry eye disease. Arch Ophthalmol. 2011 Aug;129(8):981-6. doi: 10.1001/archophthalmol.2011.200.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe-stage Glaucoma (Mean Deviation ≤ -20 dB), run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Visual Loss (CVL) at 3 months postoperatively (time frame: At 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237555, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.