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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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The purpose of this study is to determine if location of laser peripheral iridotomy (LPI) that is the standard of care treatment for angle closure glaucoma is related to changes in post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle morphology and onset of new visual disturbances.
Study hypothesis: Location of laser peripheral iridotomy affects occurrence of post-operative dysphotopsia symptoms, intraocular pressure, anterior chamber angle morphology and corneal endothelial cell count Study design: Multicenter randomized, prospective, single masked trial Trial setting: Hospitals Trial type: Treatment
Interventions: South Indian subjects aged 30 years or greater, with primary angle closure suspect (PACS) or primary angle closure/ primary angle closure glaucoma(PAC/PACG) will be randomized to either bilateral superior or nasal/temporal laser peripheral iridotomy. Subjects will undergo noninvasive testing and imaging studies to measure IOP, anterior chamber angle morphology and endothelial cell count and asked to answer a questionnaire at baseline and again at 2 weeks and 6 months after treatment Primary outcome measures: Occurrence of new self-reported general eye or dysphotopsia symptoms.
Secondary outcome measures: intraocular pressure, anterior chamber and anterior chamber angle morphology, endothelial cell count.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superior | Active Comparator | Laser peripheral iridotomy done at superior part of iris. |
|
| Nasal/temporal | Active Comparator | Laser peripheral iridotomy done at temporal/nasal part of iris. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser peripheral iridotomy | Procedure | location of laser peripheral iridotomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of new self-reported general eye or dysphotopsia symptoms | Questionnaire using a Likert scale | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | measured in mmHg | 6 Months |
| Anterior chamber angle morphology | measured in micrometers using anterior segment optical coherence tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rengaraj Venkatesh, DNB | Aravind Eye Hospital, Pondicherry | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24531024 | Background | Vera V, Naqi A, Belovay GW, Varma DK, Ahmed II. Dysphotopsia after temporal versus superior laser peripheral iridotomy: a prospective randomized paired eye trial. Am J Ophthalmol. 2014 May;157(5):929-35. doi: 10.1016/j.ajo.2014.02.010. Epub 2014 Feb 14. | |
| 22036632 | Background | Jiang Y, Chang DS, Foster PJ, He M, Huang S, Aung T, Friedman DS. Immediate changes in intraocular pressure after laser peripheral iridotomy in primary angle-closure suspects. Ophthalmology. 2012 Feb;119(2):283-8. doi: 10.1016/j.ophtha.2011.08.014. Epub 2011 Oct 29. |
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| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 6 Months |
| Corneal endothelial cell count | measured on a continuous scale | 6 Months |
| Choroidal thickness | measured in micrometers using enhanced depth optical coherence tomography | 6 Months |
| 23203700 | Background | Kumar RS, Baskaran M, Friedman DS, Xu Y, Wong HT, Lavanya R, Chew PT, Foster PJ, Aung T. Effect of prophylactic laser iridotomy on corneal endothelial cell density over 3 years in primary angle closure suspects. Br J Ophthalmol. 2013 Mar;97(3):258-61. doi: 10.1136/bjophthalmol-2012-302013. Epub 2012 Nov 30. |
| 22410350 | Background | How AC, Baskaran M, Kumar RS, He M, Foster PJ, Lavanya R, Wong HT, Chew PT, Friedman DS, Aung T. Changes in anterior segment morphology after laser peripheral iridotomy: an anterior segment optical coherence tomography study. Ophthalmology. 2012 Jul;119(7):1383-7. doi: 10.1016/j.ophtha.2012.01.019. Epub 2012 Mar 10. |
| 32672653 | Derived | Zebardast N, Kavitha S, Palaniswamy K, Kader MA, Raman G, Rajendrababu S, Ramulu PY, Rengaraj V. Predictors of Short-Term Intraocular Pressure Change after Laser Peripheral Iridotomy: A Prospective Randomized Study. Ophthalmol Glaucoma. 2018 Nov-Dec;1(3):197-205. doi: 10.1016/j.ogla.2018.10.005. Epub 2018 Oct 19. |
| 29096997 | Derived | Srinivasan K, Zebardast N, Krishnamurthy P, Abdul Kader M, Raman GV, Rajendrababu S, Venkatesh R, Ramulu PY. Comparison of New Visual Disturbances after Superior versus Nasal/Temporal Laser Peripheral Iridotomy: A Prospective Randomized Trial. Ophthalmology. 2018 Mar;125(3):345-351. doi: 10.1016/j.ophtha.2017.09.015. Epub 2017 Oct 31. |