A Trial of China Laser and Surgery Study Glaucoma in Rural China

NCT02955849 | Completed Early Phase 1 DMC

• 1 other identifier: SLT in rural China
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with medically uncontrolled open angle glaucoma in rural China, taking into account the impact of patient acceptance of each type of treatment Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty will be lower than with surgery due to higher acceptance rates among patients randomized to receive this treatment and therefore treatment provided at an earlier stage of disease progression.

Conditions

Glaucoma

Keywords

glaucoma; rural; China; SLT

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  * intraocular pressure in study eye 12 months after receiving treatment (laser or surgery) * the intraocular pressure of patients refusing their allocated intervention will still be recorded at 12 months post-refusal and will be considered in the analysis * patients accepting the allocated treatment \> 3 months after initial offer of treatment will be considered as having refused and their outcome intraocular pressure will be the last reading prior to treatment

  12 months

Secondary Outcomes (4)

• Visual quality of life

  12 months

• Satisfaction score

  12 months

• Cataract surgery

  12 months

• Allocated treatment

  12 months

Study Arms (3)

SLT laser group

EXPERIMENTAL

1. selective laser trabeculoplasty for 360 degrees the study eye. 2. Patients having 1 or 2 quadrants of angle with trabecular meshwork not visible will undergo Laser peripheral iridotomy prior to selective laser trabeculoplasty to maximize the amount of angle visible; 3. Cataract surgery will be offered if indicated and completed within 3 months of selective laser trabeculoplasty , if accepted by the patient. 4. Patients will be re-examined every 4 months and selective laser trabeculoplasty performed again according to the above protocol if intraocular pressure exceeds the target (25% reduction from the original intraocular pressure or \< 21 mmHg, whichever is lower).

Device: SLT laser

Standard care group

NO INTERVENTION

* Trabeculectomy as usually performed by the operative surgeon in one eye (study eye). * Both Mitomycin and releasable sutures are permitted if indicated in the opinion of the surgeon and s/he can perform and/or has access. * Simultaneous cataract surgery is permitted if indicated in the opinion of the operating surgeon. * Patients will be re-examined every 4 months， and Timolol 0.5% added bid if intraocular pressure exceeds the target (25% reduction from the original intraocular pressure or \< 21 mmHg, whichever is lower)

Drug treatment group

NO INTERVENTION

Patients not accepting the offered treatment for the study eye within 3 months will receive topical Timolol 0.5% bid at the usual price, with the prescription to be refilled per usual practice at the hospital (usually monthly).

Interventions

SLT laser DEVICE

Patients will be offered initial SLT laser by doctors

SLT laser group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of glaucoma (Cup to disk ratio, or CDR \> 0.6 with optic nerve appearance and/or visual field findings consistent with glaucoma in the study eye)
• angle configuration \> 180° of trabecular meshwork visible in the study eye
• no previous ocular incisional surgery or ocular laser treatment except refractive or cataract surgery in the study eye
• Best corrected visual acuity \> 6/60 metres in both eyes

You may not qualify if:

• Intraocular pressure \> 35 in the study eye
• Cup to disk ratio \> 0.9 in the study eye
• Inability to give informed consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Blindness Preventment and Treatment Department

Guangzhou, Guangdong, 510060, China

Location

Related Publications (8)

• Liang YB, Friedman DS, Wong TY, Zhan SY, Sun LP, Wang JJ, Duan XR, Yang XH, Wang FH, Zhou Q, Wang NL; Handan Eye Study Group. Prevalence and causes of low vision and blindness in a rural chinese adult population: the Handan Eye Study. Ophthalmology. 2008 Nov;115(11):1965-72. doi: 10.1016/j.ophtha.2008.05.030. Epub 2008 Aug 5.

  PMID: 18684506 BACKGROUND

• Zhang XJ, Liang YB, Liu YP, Jhanji V, Musch DC, Peng Y, Zheng CR, Zhang HX, Chen P, Tang X, Lam DS. Implementation of a free cataract surgery program in rural China: a community-based randomized interventional study. Ophthalmology. 2013 Feb;120(2):260-5. doi: 10.1016/j.ophtha.2012.07.087. Epub 2012 Oct 27.

  PMID: 23107580 BACKGROUND

• Ang GS, Varga Z, Shaarawy T. Postoperative infection in penetrating versus non-penetrating glaucoma surgery. Br J Ophthalmol. 2010 Dec;94(12):1571-6. doi: 10.1136/bjo.2009.163923. Epub 2009 Nov 5.

  PMID: 19897472 BACKGROUND

• Liu T, Congdon N, Yan X, Jin L, Wu Y, Friedman D, He M. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO). Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5271-8. doi: 10.1167/iovs.12-9798.

  PMID: 22789919 BACKGROUND

• Wittenborn JS, Rein DB. Cost-effectiveness of glaucoma interventions in Barbados and Ghana. Optom Vis Sci. 2011 Jan;88(1):155-63. doi: 10.1097/OPX.0b013e3181fc30f3.

  PMID: 21076360 BACKGROUND

• Narayanaswamy A, Leung CK, Istiantoro DV, Perera SA, Ho CL, Nongpiur ME, Baskaran M, Htoon HM, Wong TT, Goh D, Su DH, Belkin M, Aung T. Efficacy of selective laser trabeculoplasty in primary angle-closure glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2015 Feb;133(2):206-12. doi: 10.1001/jamaophthalmol.2014.4893.

  PMID: 25429421 BACKGROUND

• Realini T. Selective laser trabeculoplasty for the management of open-angle glaucoma in St. Lucia. JAMA Ophthalmol. 2013 Mar;131(3):321-7. doi: 10.1001/jamaophthalmol.2013.1706.

  PMID: 23348420 BACKGROUND

• Adekoya BJ, Akinsola FB, Balogun BG, Balogun MM, Ibidapo OO. Patient refusal of glaucoma surgery and associated factors in Lagos, Nigeria. Middle East Afr J Ophthalmol. 2013 Apr-Jun;20(2):168-73. doi: 10.4103/0974-9233.110612.

  PMID: 23741137 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Nathan G Congdon, MD,MPH

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice directior

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: November 4, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 19, 2021

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)