Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
276 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-11-30
Study Completion Date
2014-10-31
Brief Summary
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The objective of this study is to compare the long-term safety and efficacy of the Ahmed and the Baerveldt implants in patients who are undergoing aqueous shunt implant surgery for glaucoma. One eye of eligible patients will be randomized. Outcome measures include intraocular pressure, visual acuity, visual field, number of glaucoma medications, glaucoma reoperations, and complications, including suprachoroidal hemorrhage, endophthalmitis, choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.
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Detailed Description
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Background and Significance
Aqueous shunt devices have traditionally been reserved for treatment of only the most refractory glaucomas. However, more recent studies have reported favorable results in comparison with trabeculectomy in medically uncontrolled glaucomas at lower risk of filtration failure. Consequently, aqueous shunt devices have been used increasingly in glaucoma drainage surgery.
There are two principal designs of implant in common use, the Ahmed glaucoma valve implant (New World Medical, Los Ranchos, CA, USA and the Baerveldt implant (Advanced Medical Optics, Santa Ana, CA, USA).
Having both evolved from the Molteno, the Ahmed and Baerveldt devices have in common a tube portion that drains aqueous humor from the anterior chamber to a plate that is implanted on the equatorial sclera. The size of plate determines the surface area of the drainage bleb.
The Ahmed and Baerveldt implants differ in two major respects. Firstly, the plate surface area of the Baerveldt 350 implant is almost double that of the Ahmed (185 mm2). Secondly, the Ahmed has a flow-restrictor that limits early hypotony without the need for additional external ligation.
We propose a randomized prospective clinical trial comparing the long-term safety and efficacy of the Ahmed glaucoma valve implant (FP-7) with the 350-mm2 Baerveldt implant (101-350) for surgical control of secondary glaucoma and primary glaucoma in eyes that have undergone previous ocular surgery.
Objective
The objective of this study is to compare the long-term safety and efficacy of the Ahmed FP-7 implant and the 350-mm2 Baerveldt implant in patients who are undergoing aqueous shunt implant surgery. Patients who qualify for the study are randomized to receive either an Ahmed FP-7 or Baerveldt BG-101-350 implant. Only one eye of a patient may be enrolled in the study.
Outcome discrimination between the two treatment groups will be made using typical measures of visual function (visual acuity and visual field), intraocular pressure, number of glaucoma medications, and glaucoma reoperations. Emphasis will also be placed on complication rates, including suprachoroidal hemorrhage, endophthalmitis, choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.
Assignment
Since the purpose of this study is to compare the safety and efficacy of two surgical procedures used in the management of glaucoma, randomization techniques are used to assure an unbiased treatment assignment to patients.
Stratification:
Patients will be stratified by clinical center. At each Clinical Center, half of the patients will receive an Ahmed and half will receive a Baerveldt implant. Randomization takes place at the time the patient is enrolled in the study after informed consent is obtained.
Randomization:
A permuted variable block randomization scheme stratified by clinical center and type of glaucoma will be performed.
The following scenarios will constitute a failure in the ABC Study for the purposes of survival analysis:
* IOP \> 21mmHG or \< 6mmHg on 2 consecutive study visits at visits \> 3 months
* IOP reduced by \< 20% on 2 consecutive study visits at visits \> 3 months
* Reoperation for glaucoma
* Loss of light perception vision
* Removal of implant for any reason
Clinical Procedures
Visual Acuity
Visual acuity is an important outcome variable in the ABC Study. Visual acuity is measured before pupil dilation, tonometry, gonioscopy, or any other technique that could affect vision. Refraction is performed prior to formal measurement of visual acuity by either technique at the Qualifying Assessment and at the annual follow-up visits. Snellen visual acuity is measured at the Qualifying Assessment and at every follow-up visit.
Subjective refraction must be performed at the Qualifying Assessment and at the annual follow-up visits in order to determine best-corrected visual acuity. It is permissible to use a phoropter or trial frame to determine best-corrected Snellen visual acuity.
Slit Lamp Biomicroscopy Conjunctiva examination Cornea examination An assessment is made of the position and length of the tube in the eye. Anterior Chamber examination Iris examination Lens examination Tonometry Goldmann applanation tonometry is used to measure the intraocular pressure, except when irregular corneal astigmatism, corneal scarring, or corneal edema precludes accurate readings. In these cases, the Tono-Pen (Mentor) is used. The intraocular pressure is measured prior to pupillary dilation. Whenever possible, the intraocular pressure should be checked at the same time of the day as the Qualifying Assessment to minimize the effect of diurnal fluctuation The Tono-Pen (Mentor) is used in cases of corneal edema, corneal scarring, or irregular corneal astigmatism.
Central corneal thickness will be measured in each eye, by ultrasound pachymetry. A minimum of 5 measurements will be taken and the lowest recorded.
Motility Evaluation Gonioscopy Ophthalmoscopy Perimetry Visual field assessment is an important outcome measure in the ABC Study. Quantitative automated perimetry is performed using the Humphrey Field Analyzer. Visual field testing is performed before tonometry, gonioscopy, or any other technique that could affect vision. A visual field should be attempted in any eye that has sufficient vision to permit finger counting at two feet. Eyes with poor central vision may have an intact, off-center island of vision which may be measured with perimetry.
For the ABC Study, a 24-2 threshold test is performed in all patients using a size III white stimulus. Visual field testing may be performed with the Swedish Interactive Thresholding Algorithm (SITA) or full threshold strategy, but the same testing strategy must be used throughout the duration of the study. The pupil diameter should be 3 mm or greater before visual field testing is undertaken, and this may require pharmacologic dilation. Standardized refraction is performed to determine the patient's distance refraction and best-corrected visual acuity prior to visual field testing. The age appropriate plus lens is added to the distance refraction. Patient education is provided, and the instrument is set up for the test. The technician should monitor the patient during testing. Visual fields are performed preoperatively (within one month of enrollment in the study) and annually thereafter. Copies of all visual fields are faxed to the Statistical Coordinating Center for evaluation.
Surgical Procedures
The type of anesthesia is at the surgeon's discretion.
Conjunctival Flap:
An Ahmed FP-7 is used in all cases and implantation is performed in the superotemporal quadrant. A limbus-based or fornix-based conjunctival flap may be used depending on the surgeon's preference. Sufficient exposure is obtained in the superotemporal quadrant to permit placement of the Ahmed plate. A corneal traction suture or episcleral traction suture may be used to rotate the globe inferonasally to improve exposure.
Priming the Implant
A 28- or 30- gauge cannula is used to prime the Ahmed valve. Occlusion of the tube with a ligature is not permitted.
Attachment of Episcleral Plate:
The Ahmed plate is sutured to the sclera at a measured distance of 8 - 10 mm posterior to the limbus using the two fixation holes on the plate. The type of nonabsorbable suture used is of the surgeon's choice.
Preparation of Tube:
The tube is trimmed bevel-up to extend 2 to 3 mm into the anterior chamber.
Insertion of Tube into the Anterior Chamber:
A 23-gauge needle is used to enter the anterior chamber at the posterior limbus parallel to the iris plane. The Ahmed tube is inserted through this entry incision and should be well positioned in the anterior chamber away from the corneal endothelium and just above the iris. A 23-gauge needle produces an adequate entry incision for the tube without causing aqueous leakage around the tube.
Coverage of Tube:
A donor patch graft composed of donor sclera, donor cornea, or pericardium is used to cover the limbal portion of the tube. The suture selected to fixate the patch graft is of the surgeon's choice.
Conjunctival Closure:
Tenon's and conjunctiva are reapproximated to the limbus. The suture used for the conjunctival closure is determined by the surgeon in keeping with his or her usual practice.
At the surgeons discretion, a viscoelastic of his or her choice may be inserted into the anterior chamber, especially if the anterior chamber shallows after balanced salt solution is inserted.
The use of intraoperative medications is at the surgeon's discretionBaerveldt Implantation The type of anesthesia is at the surgeon's discretion.
Conjunctival Flap:
A 350-mm2 Baerveldt is used in all cases and implantation is performed in the superotemporal quadrant. A limbus-based or fornix-based conjunctival flap may be used depending on the surgeon's preference.
Scleral Exposure:
Sufficient exposure is obtained in the superotemporal quadrant to permit placement of the Baerveldt plate. A corneal traction suture or episcleral traction suture may be used to rotate the globe inferonasally and improve exposure.
Insertion of Episcleral Plate:
The 350-mm2 Baerveldt plate may be positioned under or over the superior rectus and lateral rectus muscles, depending on the surgeon's usual practice. The implant is sutured to the sclera at a measured distance of 8 - 10 mm posterior to the limbus using the two fixation holes on the plate. The type of nonabsorbable suture used is of the surgeon's choice.
Occlusion of Tube:
The Baerveldt tube must be completely occluded in all cases in order to restrict aqueous flow to the plate until it becomes encapsulated. This is done to minimize the incidence of postoperative hypotony. The method of tube occlusion is left to the discretion of the surgeon. Ligation of the tube with a polyglactin suture near the tube-plate junction, ligation with a polypropylene suture which is inserted into the anterior chamber with the tube, or internal occlusion of the tube using a "rip-cord" technique have all been used effectively. A 30-gauge cannula is used to cannulate the end of the tube and confirm complete occlusion of the tube. Following tube occlusion, the surgeon may fenestrate the tube if desired. The method of tube fenestration is left to the discretion of the surgeon.
Preparation of Tube:
The tube is trimmed bevel-up to extend 2 to 3 mm into the anterior chamber.
Insertion of Tube into the Anterior Chamber:
A 23-gauge needle is used to enter the anterior chamber at the posterior limbus parallel to the iris plane. The Baerveldt tube is inserted through this entry incision and should be well positioned in the anterior chamber away from the corneal endothelium and just above the iris. A 23-gauge needle produces an adequate entry incision for the tube without causing aqueous leakage around the tube.
Coverage of Tube:
A donor patch graft composed of donor sclera, dura mater, or pericardium is used to cover the limbal portion of the tube. The suture selected to fixate the patch graft is of the surgeon's choice.
Conjunctival Closure:
Tenon's and conjunctiva are reapproximated to the limbus. The suture used for the conjunctival closure is determined by the surgeon in keeping with his or her usual practice.
The use of intraoperative medications is at the surgeon's discretion.
Multicenter clinical trials require an organizational structure that provides efficient operations and facilitates communication. The following resource centers work together in this study:
* Clinical Centers (CC)
* Statistical Coordinating Center (SCC)
* Safety and Data Monitoring Committee (SDMC)
* Steering Committee (SC)
Aqueous shunt devices have traditionally been reserved for treatment of only the most refractory glaucomas. However, more recent studies have reported favorable results in comparison with trabeculectomy in medically uncontrolled glaucomas at lower risk of filtration failure. Consequently, aqueous shunt devices have been used increasingly in glaucoma drainage surgery.
There are two principal designs of implant in common use, the Ahmed glaucoma valve implant (New World Medical, Los Ranchos, CA, USA and the Baerveldt implant (Advanced Medical Optics, Santa Ana, CA, USA).
Having both evolved from the Molteno, the Ahmed and Baerveldt devices have in common a tube portion that drains aqueous humor from the anterior chamber to a plate that is implanted on the equatorial sclera. The size of plate determines the surface area of the drainage bleb.
The Ahmed and Baerveldt implants differ in two major respects. Firstly, the plate surface area of the Baerveldt 350 implant is almost double that of the Ahmed (185 mm2). Secondly, the Ahmed has a flow-restrictor that limits early hypotony without the need for additional external ligation.
We propose a randomized prospective clinical trial comparing the long-term safety and efficacy of the Ahmed glaucoma valve implant (FP-7) with the 350-mm2 Baerveldt implant (101-350) for surgical control of secondary glaucoma and primary glaucoma in eyes that have undergone previous ocular surgery.
Objective
The objective of this study is to compare the long-term safety and efficacy of the Ahmed FP-7 implant and the 350-mm2 Baerveldt implant in patients who are undergoing aqueous shunt implant surgery. Patients who qualify for the study are randomized to receive either an Ahmed FP-7 or Baerveldt BG-101-350 implant. Only one eye of a patient may be enrolled in the study.
Outcome discrimination between the two treatment groups will be made using typical measures of visual function (visual acuity and visual field), intraocular pressure, number of glaucoma medications, and glaucoma reoperations. Emphasis will also be placed on complication rates, including suprachoroidal hemorrhage, endophthalmitis, choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.
Assignment
Since the purpose of this study is to compare the safety and efficacy of two surgical procedures used in the management of glaucoma, randomization techniques are used to assure an unbiased treatment assignment to patients.
Stratification:
Patients will be stratified by clinical center. At each Clinical Center, half of the patients will receive an Ahmed and half will receive a Baerveldt implant. Randomization takes place at the time the patient is enrolled in the study after informed consent is obtained.
Randomization:
A permuted variable block randomization scheme stratified by clinical center and type of glaucoma will be performed.
The following scenarios will constitute a failure in the ABC Study for the purposes of survival analysis:
* IOP \> 21mmHG or \< 6mmHg on 2 consecutive study visits at visits \> 3 months
* IOP reduced by \< 20% on 2 consecutive study visits at visits \> 3 months
* Reoperation for glaucoma
* Loss of light perception vision
* Removal of implant for any reason
Clinical Procedures
Visual Acuity
Visual acuity is an important outcome variable in the ABC Study. Visual acuity is measured before pupil dilation, tonometry, gonioscopy, or any other technique that could affect vision. Refraction is performed prior to formal measurement of visual acuity by either technique at the Qualifying Assessment and at the annual follow-up visits. Snellen visual acuity is measured at the Qualifying Assessment and at every follow-up visit.
Subjective refraction must be performed at the Qualifying Assessment and at the annual follow-up visits in order to determine best-corrected visual acuity. It is permissible to use a phoropter or trial frame to determine best-corrected Snellen visual acuity.
Slit Lamp Biomicroscopy Conjunctiva examination Cornea examination An assessment is made of the position and length of the tube in the eye. Anterior Chamber examination Iris examination Lens examination Tonometry Goldmann applanation tonometry is used to measure the intraocular pressure, except when irregular corneal astigmatism, corneal scarring, or corneal edema precludes accurate readings. In these cases, the Tono-Pen (Mentor) is used. The intraocular pressure is measured prior to pupillary dilation. Whenever possible, the intraocular pressure should be checked at the same time of the day as the Qualifying Assessment to minimize the effect of diurnal fluctuation The Tono-Pen (Mentor) is used in cases of corneal edema, corneal scarring, or irregular corneal astigmatism.
Central corneal thickness will be measured in each eye, by ultrasound pachymetry. A minimum of 5 measurements will be taken and the lowest recorded.
Motility Evaluation Gonioscopy Ophthalmoscopy Perimetry Visual field assessment is an important outcome measure in the ABC Study. Quantitative automated perimetry is performed using the Humphrey Field Analyzer. Visual field testing is performed before tonometry, gonioscopy, or any other technique that could affect vision. A visual field should be attempted in any eye that has sufficient vision to permit finger counting at two feet. Eyes with poor central vision may have an intact, off-center island of vision which may be measured with perimetry.
For the ABC Study, a 24-2 threshold test is performed in all patients using a size III white stimulus. Visual field testing may be performed with the Swedish Interactive Thresholding Algorithm (SITA) or full threshold strategy, but the same testing strategy must be used throughout the duration of the study. The pupil diameter should be 3 mm or greater before visual field testing is undertaken, and this may require pharmacologic dilation. Standardized refraction is performed to determine the patient's distance refraction and best-corrected visual acuity prior to visual field testing. The age appropriate plus lens is added to the distance refraction. Patient education is provided, and the instrument is set up for the test. The technician should monitor the patient during testing. Visual fields are performed preoperatively (within one month of enrollment in the study) and annually thereafter. Copies of all visual fields are faxed to the Statistical Coordinating Center for evaluation.
Surgical Procedures
The type of anesthesia is at the surgeon's discretion.
Conjunctival Flap:
An Ahmed FP-7 is used in all cases and implantation is performed in the superotemporal quadrant. A limbus-based or fornix-based conjunctival flap may be used depending on the surgeon's preference. Sufficient exposure is obtained in the superotemporal quadrant to permit placement of the Ahmed plate. A corneal traction suture or episcleral traction suture may be used to rotate the globe inferonasally to improve exposure.
Priming the Implant
A 28- or 30- gauge cannula is used to prime the Ahmed valve. Occlusion of the tube with a ligature is not permitted.
Attachment of Episcleral Plate:
The Ahmed plate is sutured to the sclera at a measured distance of 8 - 10 mm posterior to the limbus using the two fixation holes on the plate. The type of nonabsorbable suture used is of the surgeon's choice.
Preparation of Tube:
The tube is trimmed bevel-up to extend 2 to 3 mm into the anterior chamber.
Insertion of Tube into the Anterior Chamber:
A 23-gauge needle is used to enter the anterior chamber at the posterior limbus parallel to the iris plane. The Ahmed tube is inserted through this entry incision and should be well positioned in the anterior chamber away from the corneal endothelium and just above the iris. A 23-gauge needle produces an adequate entry incision for the tube without causing aqueous leakage around the tube.
Coverage of Tube:
A donor patch graft composed of donor sclera, donor cornea, or pericardium is used to cover the limbal portion of the tube. The suture selected to fixate the patch graft is of the surgeon's choice.
Conjunctival Closure:
Tenon's and conjunctiva are reapproximated to the limbus. The suture used for the conjunctival closure is determined by the surgeon in keeping with his or her usual practice.
At the surgeons discretion, a viscoelastic of his or her choice may be inserted into the anterior chamber, especially if the anterior chamber shallows after balanced salt solution is inserted.
The use of intraoperative medications is at the surgeon's discretionBaerveldt Implantation The type of anesthesia is at the surgeon's discretion.
Conjunctival Flap:
A 350-mm2 Baerveldt is used in all cases and implantation is performed in the superotemporal quadrant. A limbus-based or fornix-based conjunctival flap may be used depending on the surgeon's preference.
Scleral Exposure:
Sufficient exposure is obtained in the superotemporal quadrant to permit placement of the Baerveldt plate. A corneal traction suture or episcleral traction suture may be used to rotate the globe inferonasally and improve exposure.
Insertion of Episcleral Plate:
The 350-mm2 Baerveldt plate may be positioned under or over the superior rectus and lateral rectus muscles, depending on the surgeon's usual practice. The implant is sutured to the sclera at a measured distance of 8 - 10 mm posterior to the limbus using the two fixation holes on the plate. The type of nonabsorbable suture used is of the surgeon's choice.
Occlusion of Tube:
The Baerveldt tube must be completely occluded in all cases in order to restrict aqueous flow to the plate until it becomes encapsulated. This is done to minimize the incidence of postoperative hypotony. The method of tube occlusion is left to the discretion of the surgeon. Ligation of the tube with a polyglactin suture near the tube-plate junction, ligation with a polypropylene suture which is inserted into the anterior chamber with the tube, or internal occlusion of the tube using a "rip-cord" technique have all been used effectively. A 30-gauge cannula is used to cannulate the end of the tube and confirm complete occlusion of the tube. Following tube occlusion, the surgeon may fenestrate the tube if desired. The method of tube fenestration is left to the discretion of the surgeon.
Preparation of Tube:
The tube is trimmed bevel-up to extend 2 to 3 mm into the anterior chamber.
Insertion of Tube into the Anterior Chamber:
A 23-gauge needle is used to enter the anterior chamber at the posterior limbus parallel to the iris plane. The Baerveldt tube is inserted through this entry incision and should be well positioned in the anterior chamber away from the corneal endothelium and just above the iris. A 23-gauge needle produces an adequate entry incision for the tube without causing aqueous leakage around the tube.
Coverage of Tube:
A donor patch graft composed of donor sclera, dura mater, or pericardium is used to cover the limbal portion of the tube. The suture selected to fixate the patch graft is of the surgeon's choice.
Conjunctival Closure:
Tenon's and conjunctiva are reapproximated to the limbus. The suture used for the conjunctival closure is determined by the surgeon in keeping with his or her usual practice.
The use of intraoperative medications is at the surgeon's discretion.
Multicenter clinical trials require an organizational structure that provides efficient operations and facilitates communication. The following resource centers work together in this study:
* Clinical Centers (CC)
* Statistical Coordinating Center (SCC)
* Safety and Data Monitoring Committee (SDMC)
* Steering Committee (SC)
Conditions
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Glaucoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Ahmed implant,1
Ahmed glaucoma drainage implant for intraocular pressure control
Group Type
ACTIVE_COMPARATOR
Ahmed implant
Intervention Type
DEVICE
placement of glaucoma drainage device to control intraocular pressure
Baerveldt implant
Baerveldt glaucoma drainage implant for intraocular pressure control
Group Type
ACTIVE_COMPARATOR
Baerveldt implant
Intervention Type
DEVICE
placement of glaucoma drainage device to control intraocular press
Interventions
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Ahmed implant
placement of glaucoma drainage device to control intraocular pressure
Intervention Type
DEVICE
Baerveldt implant
placement of glaucoma drainage device to control intraocular press
Intervention Type
DEVICE
Other Intervention Names
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Ahmed fp7
Baerveldt 350
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 85 years, inclusive.
* Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg.
* Glaucoma drainage implant as planned surgical procedure.
* POAG with previous failed trabeculectomy or other intraocular surgery.
* Secondary glaucoma with or without previous intraocular surgery
* Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg.
* Glaucoma drainage implant as planned surgical procedure.
* POAG with previous failed trabeculectomy or other intraocular surgery.
* Secondary glaucoma with or without previous intraocular surgery
Exclusion Criteria
* Unwilling or unable to give consent or unwilling to accept randomization.
* Patient out of area and potentially unavailable for follow-up visits
* No light perception.
* Uveitis secondary to Juvenile Idiopathic Arthritis
* Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye.
* Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation.
* Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation.
* Vitreous sufficient to require a vitrectomy present in the anterior chamber at the time of surgery.
* Patient out of area and potentially unavailable for follow-up visits
* No light perception.
* Uveitis secondary to Juvenile Idiopathic Arthritis
* Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye.
* Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation.
* Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation.
* Vitreous sufficient to require a vitrectomy present in the anterior chamber at the time of surgery.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Eye Institute (NEI)
NIH
Sponsor Role
collaborator
Research to Prevent Blindness
OTHER
Sponsor Role
collaborator
University of Miami
OTHER
Sponsor Role
lead
Responsible Party
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Donald L. Budenz
Study Chairman
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Donald L Budenz, M.D.,M.P.H.
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Keith Barton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Moorfields Eye Hospital NHS Foundation Trust
William J Feuer, M.S.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States
Site Status
Countries
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United States
References
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Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, Bacharach J, Panek WC. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995 Jul;120(1):23-31. doi: 10.1016/s0002-9394(14)73755-9.
Reference Type
BACKGROUND
Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, Panek WC, Wilson MR. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999 Aug;128(2):198-204. doi: 10.1016/s0002-9394(99)00080-x.
Reference Type
BACKGROUND
Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, LaBree L, Heuer DK. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994 Aug;101(8):1456-63; discussion 1463-4. doi: 10.1016/s0161-6420(94)31152-3.
Reference Type
BACKGROUND
Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, Varma R. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999 Dec;106(12):2312-8. doi: 10.1016/S0161-6420(99)90532-8.
Reference Type
BACKGROUND
Wang JC, See JL, Chew PT. Experience with the use of Baerveldt and Ahmed glaucoma drainage implants in an Asian population. Ophthalmology. 2004 Jul;111(7):1383-8. doi: 10.1016/j.ophtha.2003.11.005.
Reference Type
BACKGROUND
Tsai JC, Johnson CC, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a single-surgeon comparison of outcome. Ophthalmology. 2003 Sep;110(9):1814-21. doi: 10.1016/S0161-6420(03)00574-8.
Reference Type
BACKGROUND
Nguyen QH, Budenz DL, Parrish RK 2nd. Complications of Baerveldt glaucoma drainage implants. Arch Ophthalmol. 1998 May;116(5):571-5. doi: 10.1001/archopht.116.5.571.
Reference Type
BACKGROUND
Barton K, Gedde SJ, Budenz DL, Feuer WJ, Schiffman J; Ahmed Baerveldt Comparison Study Group. The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications. Ophthalmology. 2011 Mar;118(3):435-42. doi: 10.1016/j.ophtha.2010.07.015. Epub 2010 Oct 8.
Reference Type
RESULT
Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011 Mar;118(3):443-52. doi: 10.1016/j.ophtha.2010.07.016. Epub 2010 Oct 8.
Reference Type
RESULT
Barton K, Feuer WJ, Budenz DL, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Three-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2014 Aug;121(8):1547-57.e1. doi: 10.1016/j.ophtha.2014.01.036. Epub 2014 Apr 24.
Reference Type
RESULT
Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.
Reference Type
RESULT
Other Identifiers
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20057138
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
NCT05797350
UNKNOWN
NA
Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
NCT00893490
UNKNOWN
PHASE1
Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Glaucoma
NCT01633775
COMPLETED
The Results of Ahmed Valve Operations
NCT00193960
UNKNOWN
The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases
NCT04214847
COMPLETED
NA
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
NCT01883856
COMPLETED
NA
Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
NCT06983704
COMPLETED
EARLY_PHASE1
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma
NCT00371072
COMPLETED
PHASE2/PHASE3
A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy
NCT00597181
TERMINATED
PHASE4
Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
NCT01814514
UNKNOWN
PHASE2
Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves
NCT01535768
UNKNOWN
PHASE4
Baerveldt Plate Area Comparison (BPAC)
NCT01159314
TERMINATED
NA
Aqueous Dynamics and Glaucoma Surgeries
NCT02839590
UNKNOWN
AADI Glaucoma Shunt - a Quality Control Study
NCT03850054
TERMINATED
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
NCT03634319
TERMINATED
NA
XEN Glaucoma Gel Stent Versus Trabeculectomy
NCT05439161
RECRUITING
NA
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
NCT00382395
SUSPENDED
PHASE3
Long Term Outcome After Ahmed Glaucoma Valve
NCT01741961
COMPLETED
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
NCT00869141
COMPLETED
PHASE4
Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma
NCT04072016
TERMINATED
NA
Intraluminal Stenting Versus External Ligation of Ahmed Glaucoma Valve
NCT04508881
COMPLETED
NA