| Primary | Number of Participants With Surgical Failure | Surgical failure is defined as:
- Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months)
- Reoperation for glaucoma
- Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months)
- Loss of light perception vision
| The number of participants requiring glaucoma operations includes only those that had a failed surgery due to glaucoma reoperation. | Posted | | Count of Participants | | Participants | | Up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
| | | Title | Denominators | Categories |
|---|
| Inadequate IOP reduction | | | | Reoperation for Glaucoma | | |
| |
| Secondary | Intraocular Pressure | Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen. | Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete the IOP assessment. | Posted | | Mean | Standard Deviation | mmHg | | At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
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| Secondary | Number of Participants With Reported Postoperative Complications | Number of participants with early and late postoperative complications will be reported as per treating physician assessment | | Posted | | Count of Participants | | Participants | | Up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
| |
| Secondary | Visual Acuity Using a Snellen Chart | Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | Not all participants were able to complete the 5 year follow up visit and assessments. | Posted | | Mean | Standard Deviation | logMAR | | At Baseline, At 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
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| Secondary | Visual Acuity as Measured Using EDTRS Chart | Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity. | Not all participants were able to complete the 5 year follow up visit and assessments. | Posted | | Mean | Standard Deviation | letters | | At baseline, At 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
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| Secondary | Visual Field | Visual fields will be measured using standard automated perimetry. | No data is reported for this outcome as data can not be extracted from system despite exhausting all efforts to do so. | Posted | | | | | | Up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
| |
| Secondary | Reoperation for Glaucoma | The number of participants requiring reoperation for glaucoma will be reported | The number of participants requiring glaucoma operations includes those that had a failed surgery due to glaucoma reoperation, as well as, other patients who failed because of inadequate intraocular pressure reduction and subsequently underwent glaucoma surgery. | Posted | | Count of Participants | | Participants | | Up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
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| Secondary | Number of Glaucoma Medications | The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used | Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete assessment. | Posted | | Mean | Standard Deviation | glaucoma medications used | | At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years | | | | ID | Title | Description |
|---|
| OG000 | Tube Shunt Surgery Group | Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye. | | OG001 | Trabeculectomy With Mitomycin C | Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb. Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes |
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