Randomized Noninferiority Trial of Direct Selective Laser Trabeculoplasty in Open-Angle Glaucoma and Ocular Hypertension
Bibliographic record
Abstract
PURPOSE: Effective glaucoma treatment is limited by nonadherence to medications and access to selective laser trabeculoplasty (SLT). The GLAUrious study compared automated, gonioscopy-free, noncontact, image-guided direct selective laser trabeculoplasty (DSLT) with conventional SLT in open-angle glaucoma (OAG) and ocular hypertension (OHT) to reduce intraocular pressure (IOP). DESIGN: Prospective, multicenter, randomized, controlled, evaluator-masked noninferiority trial. PARTICIPANTS: Participants aged ≥ 40 years with OAG or OHT, on 0-3 hypotensive medications at screening, and washout IOP of 22-35 mmHg at 14 centers. METHODS: After washout, 192 participants randomized 1:1 to DSLT (n = 99) or SLT (n = 93). Intraocular pressure was assessed before treatment and through 12 months after the procedure, with washout IOP at baseline and 6 months. MAIN OUTCOME MEASURES: Difference between DSLT and SLT in mean IOP change from baseline to 6 months (noninferiority margin, -1.95 mmHg). Exploratory efficacy and safety outcomes were assessed over 12 months. RESULTS: Of 156 participants (81.3%) without major protocol deviations analyzed at 6 months, the mean ± standard error (SE) washout IOP reduction from baseline was 5.5 ± 0.5 mmHg (-20.6%) after DSLT and 6.2 ± 0.5 mmHg (-23.6%) after SLT. The between-group difference (SLT-DSLT) in mean IOP reduction was -0.7 mmHg (95% confidence interval [CI], -2.2 to 0.8 mmHg; P = 0.09 [not significant] for noninferiority). Of 161 participants (83.9%) without major protocol deviations analyzed at 12 months, mean ± SE nonwashout IOP reduction from screening was 3.2 ± 0.4 mmHg (-12.2%) after DSLT and 3.2 ± 0.4 mmHg (-9.4%) after SLT. The between-group difference in mean IOP reduction was 0.01 mmHg (95% CI, -1.1 to 1.1 mmHg; P < 0.001 for noninferiority). Safety profiles were similar between groups, although clinically nonsignificant punctate subconjunctival hemorrhage was more frequent in the DSLT group. Ocular AEs generally were mild and resolved without intervention. CONCLUSIONS: The 6-month primary end point did not achieve statistical noninferiority compared with conventional SLT. Nonetheless, DSLT was well tolerated and provided an effective reduction in IOP that was sustained for 12 months. Failure to demonstrate noninferiority does not prove inferiority; DSLT remains an effective option in the early treatment paradigm and can be considered as a first-line treatment when SLT is not readily accessible. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".