Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT
Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated With Selective Laser Trabeculoplasty (SLT)
This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients.
Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT.
The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment.
The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.
調査の概要
詳細な説明
This is a prospective, single-arm, interventional study designed to evaluate the safety and effectiveness of direct selective laser trabeculoplasty (DSLT) using the Voyager™ DSLT system in patients with ocular hypertension or primary open-angle glaucoma who have previously undergone selective laser trabeculoplasty (SLT).
DSLT is a non-contact laser procedure that delivers energy to the trabecular meshwork through the limbus without requiring a gonioscopy lens. The procedure in this study is standardized, consisting of 120 laser applications delivered over 360 degrees using a 400 µm spot size and fixed energy of 1.8 mJ, without titration. Treatment is performed in a single eye per participant.
To minimize the confounding effects of topical ocular hypotensive medications, participants using such therapies at screening will undergo a protocol-defined washout period prior to baseline intraocular pressure (IOP) assessment and treatment. Additional washout is required prior to the 6-month follow-up assessment to allow for evaluation of treatment effect independent of adjunctive pharmacologic therapy.
IOP is measured using Goldmann applanation tonometry at defined study visits. During follow-up, initiation of IOP-lowering medications is permitted based on investigator-defined target IOP thresholds and clinical judgment. Criteria for treatment escalation and definitions of treatment failure, including the need for secondary glaucoma procedures or ocular surgery that may affect IOP, are specified in the protocol.
This study specifically evaluates the performance of DSLT in a population with prior SLT exposure, for whom the magnitude and durability of response to repeat or alternative laser therapy are not well established. The study is intended to generate data on IOP control and safety outcomes in this clinically relevant subgroup under standardized treatment and follow-up conditions.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Krystina Tavarez Feliciano, B.A
- 電話番号：718-519-1000
- メール：krystinafeliciano23@gmail.com
研究場所
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New York
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The Bronx、New York、アメリカ、10469
- New York Eye Surgery Center
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
• Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye.
- Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG).
- Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 through 32 mm Hg.
Exclusion Criteria:
• Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0)
Previous glaucoma surgeries/interventions:
- Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
- Recent SLT failures (within 6 months of initial treatment).
- Patients who have undergone cataract surgery within the prior 2 years.
Secondary glaucoma:
o Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.
- Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：DSLT Treatment
Participants undergo direct selective laser trabeculoplasty (DSLT) in one eye using a fixed-energy protocol (120 shots, 400 µm spot size, 1.8 mJ, no titration).
Intraocular pressure (IOP) is assessed at baseline (following medication washout) and during follow-up visits at 1 month, 3 months, and 6 months.
A medication washout is required prior to baseline and the 6-month assessment.
IOP-lowering medications may be introduced during follow-up based on investigator-defined thresholds.
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Eligible participants will undergo the DSLT procedure: 120 shots, 400 µm spot size, 1.8mJ fixed energy (no titration) delivered at the limbus over 2.4 seconds
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated with Selective Laser Trabeculoplasty (SLT)
時間枠：baseline through 6 months post DSLT treatment
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IOP measured using Goldmann applanation tonometry.
Washed-out IOP assessed at baseline prior to DSLT and at 6 months post-treatment following protocol-defined medication washout.
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baseline through 6 months post DSLT treatment
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協力者と研究者
捜査官
- 主任研究者：Nathan Radcliffe, M.D.、New York Eye Surgery Center
出版物と役立つリンク
一般刊行物
- Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JK, Miller JP, Parrish RK, Wilson MR; Ocular Hypertension Treatment Study Group. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.
- Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. Primary open-angle glaucoma in blacks: a review. Surv Ophthalmol. 2003 May-Jun;48(3):295-313. doi: 10.1016/s0039-6257(03)00028-6.
- 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.
- Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167/tvst.10.3.5.
- Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.
- Hughes BA, Bacharach J, Craven ER, Kaback MB, Mallick S, Landry TA, Bergamini MV. A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. J Glaucoma. 2005 Oct;14(5):392-9. doi: 10.1097/01.ijg.0000176935.08392.14.
- Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016/j.ophtha.2022.09.009. Epub 2022 Sep 17.
- Remo S, Roberto M. Staging Glaucoma Patient: Why and How?. Open Ophthalmol J, 2009; 3: http://dx.doi.org/10.2174/1874364100903010059
- Supriya M Buraniya et al., Change in IOP after Selective Laser Trabeculoplasty in North Indian Primary Open Angle Glaucoam Patients: A Prospective Analytical Study. Journal of Clinical and Diagnostic Research. 2024 Nov, Vol-18(11): NC01-NC06
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