Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study

Shokoohi-Rad, Saeed; Karimi, Farshid; Zarei‐Ghanavati, Siamak; Tireh, Hossein

doi:10.1177/1120672119879331

Cited by 22 publications

(22 citation statements)

References 38 publications

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“… 25 26 However, the evidence was mainly retrospective. 27 The above proof indicates that goniotomy could be an adjunct to PEI in the treatment of advanced PACG. 25 However, high-quality RCTs to validate the efficacy and safety of MIGS compared with phacotrabeculectomy are still lacking.…”

Section: Introductionmentioning

confidence: 78%

Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)

Song

Zhang

et al. 2021

BMJ Open

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IntroductionPrimary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.Methods and analysisThis is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.Ethics and disseminationEthical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04878458.

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Section: Introductionmentioning

confidence: 78%

Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)

Song

Zhang

et al. 2021

BMJ Open

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“…GT, the most popular type of MIGS, has been successfully adopted for PACG using Kahook Dual Blade, [19][20][21] Tanito Microhook, 22 23 or other microhooks or gonioscopy-assisted transluminal trabeculotomy. [24][25][26] However, the evidence was mainly retrospective. 27 An ongoing randomised controlled trial (RCT) is comparing phacotrabeculectomy and phacogoniotomy (PEI+GSL+GT) ( ClinicalTrials.…”

Section: Open Accessmentioning

confidence: 99%

“…Additive IOP-lowering is thus obtained for advanced PACG. GT, the most popular type of MIGS, has been successfully adopted for PACG using Kahook Dual Blade,19–21 Tanito Microhook,22 23 or other microhooks or gonioscopy-assisted transluminal trabeculotomy 24–26. However, the evidence was mainly retrospective 27.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)

Gao

Lin

et al. 2022

BMJ Open

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IntroductionPrimary angle-closure glaucoma (PACG) is a major subtype of glaucoma that accounts for most bilateral glaucoma-related blindness globally. Filtering surgery is a conventional strategy for PACG, yet it has a long learning curve and undesirable disastrous complications. Minimally invasive glaucoma surgery (MIGS) plays an increasing role in the management of glaucoma due to its safer and faster recovery profile; cataract surgery-based MIGS is the most commonly performed such procedure in PACG. However, for patients with a transparent lens or no indications for cataract extraction, incorporation of MIGS into PACG treatment has not yet been reported. Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interno goniotomy in advanced PACG with no or mild cataracts.Methods and analysisThis non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. Eighty-eight patients with no or mild cataracts and advanced PACG will be enrolled and randomised to undergo trabeculectomy or peripheral iridectomy plus ab interno goniotomy. Enrolled patients will undergo comprehensive ophthalmic examinations before and after surgery. The primary outcome is intraocular pressure (IOP) at 12 months postoperatively. The secondary outcomes are cumulative success rate of surgery, surgery-related complications and number of IOP-lowering medications. Participants will be followed up for 36 months postoperatively.Ethics and disseminationThe study protocol was approved by the ethical committees of the Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ191) and of all subcentres. All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings.Trial registration numberNCT05163951.

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confidence: 99%

“…We have read the article entitled, “Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study” by Shokoohi-Rad et al 1 We would like to congratulate the authors on their research and provide our own constructive insights.…”

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confidence: 99%

Critique of the study, “Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study” by Shokoohi-Rad et al.

Mercer

Alaghband

2021

European Journal of Ophthalmology

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Dear Editor,We have read the article entitled, "Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study" by Shokoohi-Rad et al. 1 We would like to congratulate the authors on their research and provide our own constructive insights.We have some concerns regarding the recruitment process. Although the patients were randomised, it is not clear how the patients were initially selected. Also, a large proportion of patients were excluded. In the "flowchart of patient selection", one-hundred-and-ten patients were assessed for eligibility and forty of these were excluded. Of these, twelve were excluded for "other reasons" unknown to the reader. This raises concerns over selection bias. Furthermore, there are seven patients who were lost to follow-up who were not included in the final analysis. An intention to treat analysis would have reduced attrition bias. 2 The authors claim that this study shows that phacoemulsification combined with visco-goniosynechialysis and goniotomy is superior to phacoemulsification with visco-goniosynechialysis only in lowering intra-ocular pressure (IOP). However, on review of the numbers, it appears that there is significant overlap of the standard deviations of the two groups. The statistically significant result should be questioned. Furthermore, despite having no power calculation, we can assume this is an under powered study with a sample size of just sixtythree patients split across the two groups. Also, there are six outliers within the visco-goniosynechialysis and goniotomy group, three with a marked IOP rise and one with very low IOP. It would be helpful to elaborate on those cases.Finally, we arrive at the issue of external validity. The patients in this trial were recruited from a single centre in Iran. The severity of glaucoma based on Hodapp or similar classifications of participants is not clear. We know they had an average cup to disc ratio of 0.65 and 0.68 in the goniotomy versus non-goniotomy group respectively. However, visual field test results are not disclosed. Can we assume that that the patient population is Iranian with moderate glaucoma?To conclude, before we can confidently use goniotomy, which has risks of hyphaema and hypotony as demonstrated in this study, we should acknowledge the pit-falls of this trial and adapt our clinical practice cautiously. A third arm undergoing phacoemulsification alone would have also been insightful.

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Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study

Cited by 22 publications

References 38 publications

Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)

Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study)

Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)

Critique of the study, “Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study” by Shokoohi-Rad et al.

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