Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification

Study Overview
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Brief Summary
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In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups [NPDS and PE and autotransplantation of human anterior lens capsule (ALC) and NPDS and PE alone]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.

Official Title
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Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial

Conditions
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Glaucoma, Cataract

Intervention / Treatment
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* Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule
* Procedure: Non-penetrating deep sclerectomy and phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with concomitant uncontrolled glaucoma and significant cataract Progression in glaucoma despite medical treatment Age more than 18 years old Exclusion criteria Prior ocular surgery Neovascular glaucoma or uveitic glaucoma Compromised ocular surface or insufficient conjunctiva

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule<br>The intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake. | Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule<br>* This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.<br>|
| Active Comparator: Non-penetrating deep sclerectomy and phacoemulsification<br>The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer. | Procedure: Non-penetrating deep sclerectomy and phacoemulsification<br>* This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline intraocular pressure at month 1 follow up | The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up | Baselines and month 1 follow up | 
| Change from baseline intraocular pressure at month 3 follow up | The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up | Baselines and month 3 follow up | 
| Change from baseline intraocular pressure at month 6 follow up | The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up | Baselines and month 6 follow up | 
| Change from baseline intraocular pressure at month 12 follow up | The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up | Baselines and month 12 follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complete success rate at month 3 follow up | The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 3 follow up. | Month 3 follow up | 
| The complete success rate at month 1 follow up | The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 1 follow up. | Month 1 follow up | 
| The complete success rate at month 6 follow up | The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 6 follow up. | Month 6 follow up | 
| The complete success rate at month 12 follow up | The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 12 follow up. | Month 12 follow up | 
| The qualified success rate at month 3 follow up | The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 3 followup. | Month 3 follow up | 
| The qualified success rate at month 6 follow up | The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 6 followup. | Month 6 follow up | 
| The qualified success rate at the month 12 follow up | The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 12 followup. | Month 12 follow up | 
| The qualified success rate at the month 1 follow up | The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 1 followup. | Month 1 follow up | 
| Change from baseline the number of glaucoma medications at month 1 follow up | The number of glaucoma medications will be assessed at baseline and month 1 follow up. | Baseline and month 1 follow up | 
| Change from baseline the number of glaucoma medications at month 3 follow up | The number of glaucoma medications will be assessed at baseline and month 3 follow up. | Baseline and month 3 follow up | 
| Change from baseline the number of glaucoma medications at month 6 follow up | The number of glaucoma medications will be assessed at baseline and month 6 follow up. | Baseline and month 6 follow up | 
| Change from baseline the number of glaucoma medications at month 12 follow up | The number of glaucoma medications will be assessed at baseline and month 12 follow up. | Baseline and month 12 follow up | 
| Change from baseline the best-corrected visual acuity at month 6 follow up | The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up. | Baseline and month 6 follow up | 
| Change from baseline the best-corrected visual acuity at month 12 follow up | The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up. | Baseline and month 12 follow up | 
| Complications at month 1 follow up | The complications of surgery will be assessed at month 1 follow up. | Month 1 follow up | 
| Complications at month 3 follow up | The complications of surgery will be assessed at month 3 follow up. | Month 3 follow up | 
| Complications at month 6 follow up | The complications of surgery will be assessed at month 6 follow up. | Month 6 follow up | 
| Complications at month 12 follow up | The complications of surgery will be assessed at month 12 follow up. | Month 12 follow up | 
| Need to postoperative needling and laser goniopuncture at month 1 follow up | Need to postoperative needling and laser goniopuncture at month 1 follow up | Month 1 follow up | 
| Need to postoperative needling and laser goniopuncture at month 3 follow up | Need to postoperative needling and laser goniopuncture at month 3 follow up | Month 3 follow up | 
| Need to postoperative needling and laser goniopuncture at month 6 follow up | Need to postoperative needling and laser goniopuncture at month 6 follow up | Month 6 follow up | 
| Need to postoperative needling and laser goniopuncture at month 12 follow up | Need to postoperative needling and laser goniopuncture at month 12 follow up | Month 12 follow up |