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

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

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.

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.

The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.

Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.

The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up

The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up

The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up

The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and 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 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 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 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 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 3 followup.

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.

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.

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.

The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.

The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.

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