IOP DecreasedNVGNCT04143620
Triple Procedure for Dense Cataractus Neovascular Glaucoma Patients
A study testing Procedure in people with IOP Decreased and Visual Impairment, run by Minia University at 1 site in Egypt.
Trial summary
Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions. Read more about this study
- Who is it for?
- Ages 47 to 66 years
- Conditions the study is for
- IOP Decreased, Visual Impairment
- What is being tested?
- Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2016to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study included patients with uncontrolled angle closure dense cataractus NVG with maximum tolerated anti-glaucoma medications.
Who cannot join
- Excluded from this study eyes that had previous anti-glaucoma procedures, silicone oil filled eyes, previous buckle surgery or Conjunctival scaring from any cause, eyes with clear crystalline lens or faint cataract, eyes with corneal opacity, and eyes with visual acuity less than hand motion with good perception of light.
Trial locations and contacts
1 site in 1 country.
About this study
Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions.
Methods: A total of 12 eyes of 12 patients with dense cataractus NVG patients were included in this study. The patients mean age was 57.25 ± 5.9 years. The mean pre-operative intraocular pressure (IOP) was 47.25 ± 4.04 mmHg with maximum antiglaucoma therapy. The mean best corrected distant visual acuities (BCDVA) in log MAR was 2.13 ± 0.38. All the patients received intra-vitreal injection of 1.25 mg (0.05 ml) bevacizumab followed by phacoemulsification, pars plana vitrectomy (PPV) including pan-retinal photocoagulation (PRP), and assisted trabeculectomy with Mitomycin c (MMC). Mean IOP and BCDVA changes were the main outcome results of this study.
Read the detailed description
Introduction Ocular ischemia due to diabetic retinopathy (DR) and central retinal vein occlusion (CRVO) are the most common causes that contribute to the development of neovascular glaucoma (NVG). Ischemic retina derived factors like vascular endothelial growth factor (VEGF) that can affect the anterior segment and initiates neovascularization in the iris (NVI), neovascularization in the angle (NVA). Aqueous outflow is obstructed when neovascular fibrous tissues block the trabecular meshwork and leads to synechial angle closure, thus NVG develops. Intraocular pressure (IOP) rise due to NVG lowers the ocular perfusion leading to further retinal ischemia, and this in turn induces more neovascularization. The management of NVG is very difficult thus; the conventional treatments such as antiglaucoma drugs, trabeculectomy, cyclophotocoagulation and cyclocryotherapy have poor success rates. It is very important to reduce the ischemic drive promptly for the treatment of NVG. Pan-retinal photocoagulation (PRP) is a mandatory and effective in resolving the ischemic condition and decreasing the vasoproliferative factors production.[ This management is particularly difficult in eyes with dense cataract. However, it is possible to overcome this difficulty by doing phacoemulsification and pars plana vitrectomy (PPV) + PRP. Moreover, phacoemulsification combined with PPV enables us to apply PRP from the posterior pole to the ora serrata peripherally. It has been known that Mitomycin C (MMC) increase the success rate of trabeculectomy in patients with NVG. Therefore, in the current study, we performed Intravitreal bevacizumab (IVB) injection, phacoemulsification, PPV + PRP and trabeculectomy augmented with subconjunctival injection of MMC.
The aim of this study is to evaluate safety and efficacy of this combined surgical procedure to alleviate retinal ischemia, reduce IOP, and improve visual acuity in dense cataractus NVG patients.
Subjects and Methods
Twelve eyes of 12 patients with NVG associated with dense cataract enough to obscure fundus visualization (7 males, 5 females) were included in the study in the period from July 2016 to August 2019 at Ophthalmology Department, Faculty of Medicine, Minia University. The patient's age ranged from 47 to 66 years with a mean age of 57.25 ± 5.9 years. The underlying cause for NVG was diabetes mellitus (DM) in 8 eyes (75%) and CRVO in 4 eyes (33.33%). Vitreous hemorrhage was present in half (50%) of the patients. The study was approved by the Local Ethical Review Committee and adhered to the tents of Declaration of Helsinki as well as all patients singed a written consent after discussion of the potential benefits and risks of this triple surgical procedures.
Preoperative examinations: Routine ophthalmological examinations were done after history taking including, age, sex, laterality, etiology of NVG and number of used anti-glaucoma drugs. The ocular examination includes estimation of visual acuity, IOP measurement with Goldman applanation tonometer, slit lamp examination of anterior segment, gonioscopy examination of angle of anterior chamber, biometry and ultrasonography. The demographic data were registered as in (Table 1).
Surgical procedures . In brief: - All procedures were done under peribulbar anesthesia with mild systemic sedation. IVB injection of 1.25 mg (0.05 ml) was given 2-6 days before surgery using a 27-gauge needle at the inferotemporal quadrant at 3.5-4.0 mm posterior to the limbus. Preoperative IV mannitol was given to all cases to lower IOP before surgery beside the full anti-glaucoma drugs including: topical Dorzolamide-Timolol combination, Brimonidine tartrate and oral Acetazolamide (250 mg) three times a day. Subconjunctival injection of MMC in a dose of 0.04mg/ml was done, and a period of 4 minutes was left before Conjunctival opening.
Fornix based Conjunctival incision was performed and a rectangular scleral flap of 3x4 mm was dissected. Separate temporal clear corneal incision phacoemulsification was done with intrabagal one-piece hydrophobic IOL implantation. Then, incision was closed with 10/0 nylon suture. This was followed by three ports 25-G PPV including core vitrectomy, injection of triamcinolone acetonide, induction of PVD, shaving of vitreous base, and dealing with any epiretinal membranes. PRP using diode endo-laser was done up to the far periphery (2000-3000 shots, duration 200 ms; power 400 mw). Fluid-air exchange was then performed and 20% SF6 was injected leaving 10 cc of gas to adjust pressure at the end of surgery. Then, the upper sclerotomies were sutured by vicryl 7/0 and the infusion cannula was left in place connected to the syringe of 20% SF6. Then, Healon was injected into the anterior chamber to maintain depth of anterior chamber and trabeculectomy by Kelly punch and peripheral iridectomy were done. Scleral flap was sutured by two 10/0 nylon sutures at the corners followed by watertight Conjunctival wound closure. More SF6 was injected to adjust IOP and the infusion cannula was removed, and its site was sutured with vicryl 7/0 suture. At the end of surgery, fluid was injected into the AC to test for filtration of bleb and to make sure that the conjunctiva was closed watertight. At last, triamcinolone acetonide subtenon injection was given to all eyes.
Post-operative management: The patients were prescribed prednisolone 1% (predfort, Alcon Co.) eye drops QID and tapered through 8 weeks, cyclopentolate 0.5 % TID, moxifloxacin 0.3 mg (Vigamox, Alcon Co.) eye drops QID for 2 weeks and ointment of tobramycin and dexamethasone at night for 4 weeks. Scheduled follow up visits were advised next postoperative day, one week, two weeks, monthly for three months, and then each three months for 2 years.
All patients underwent full ophthalmologic examination including BCDVA, IOP, gonioscopy, slit lamp examination, and dilated fundus examination. Antiglaucoma medications were prescribed if IOP was more than 21 mmHg. Baseline results and that of 1, 3 and 6 months, 1 and 2 years were included in the statistical analysis. This study main outcome measures were the mean BCDVA (log MAR), the mean IOP and the incidence of complications. Successful surgery was considered when the target IOP =21 mmHg was achieved without serious complications such as suprachoroidal hemorrhage, choroidal effusion, retinal detachment, endophthalmitis, phthisis bulbi, or persistent hypotony (IOP <5 mmHg). Complete success was considered when IOP of 6 -21 mmHg was achieved without any anti-glaucoma drugs, and qualified success when this target IOP was achieved with and without the use of anti-glaucoma drugs. Failure was defined as IOP >21 mmHg despite the use of maximum tolerated medications, hypotony, or the need for another glaucoma surgery.
Statistical analysis: Statistical analysis was performed with SPSS 19. Data were expressed as mean ± standard deviation (SD). Changes in the mean BCDVA and the mean IOP were compared for each follow up visit with baseline using paired t test and graphs construction done by using Graph Pad Prism 5 program. P value < 0.05 was considered statistically significant.
- Conditions
- IOP Decreased, Visual Impairment
- Being tested
- Procedure
- Medical subject headings
- Ocular Hypotension, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcedureProcedure or surgery
Also called Triple procedure
Triple procedure
| Study group | Role | What they receive |
|---|---|---|
| Neovascular glaucoma | Other | Neovascular glaucoma patients underwent triple procedure Receives: Procedure: Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCDVA
Best corrected distant visual acuity
Measured: 2 years
IOP
Intra-ocular pressure
Measured: 2 years
Secondary outcomes (1)
Post-operative complications
Post-operative complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jul 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IOP DecreasedStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Manegment of uncontrolled NVG patients with dense cataract
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaaban Elwan, Minia University
- Investigators
- Hossam M Moharram, MD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143620
- Sponsor's protocol ID
- Minia University, NVG
- Acronym
- NVG
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of the study
Publications
Moharram HM, Abd-Elhamid Mehany Elwan S, Nassar MM, Abdelkader MF. Triple Procedure for Dense Cataractous Neovascular Glaucoma Patients. J Ophthalmol. 2020 Jun 21;2020:1251203. doi: 10.1155/2020/1251203. eCollection 2020.
PubMed 32655940
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Procedure for Dense Cataractus Neovascular Glaucoma Patients
- ClinicalTrials.gov ID
- NCT04143620
- Acronym / sponsor ID
- NVG / Minia University, NVG
- Conditions
- IOP Decreased, Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions.
Methods: A total of 12 eyes of 12 patients with dense cataractus NVG patients were included in this study. The patients mean age was 57.25 ± 5.9 years. The mean pre-operative intraocular pressure (IOP) was 47.25 ± 4.04 mmHg with maximum antiglaucoma therapy. The mean best corrected distant visual acuities (BCDVA) in log MAR was 2.13 ± 0.38. All the patients received intra-vitreal injection of 1.25 mg (0.05 ml) bevacizumab followed by phacoemulsification, pars plana vitrectomy (PPV) including pan-retinal photocoagulation (PRP), and assisted trabeculectomy with Mitomycin c (MMC). Mean IOP and BCDVA changes were the main outcome results of this study.
Detailed description
Introduction Ocular ischemia due to diabetic retinopathy (DR) and central retinal vein occlusion (CRVO) are the most common causes that contribute to the development of neovascular glaucoma (NVG). Ischemic retina derived factors like vascular endothelial growth factor (VEGF) that can affect the anterior segment and initiates neovascularization in the iris (NVI), neovascularization in the angle (NVA). Aqueous outflow is obstructed when neovascular fibrous tissues block the trabecular meshwork and leads to synechial angle closure, thus NVG develops. Intraocular pressure (IOP) rise due to NVG lowers the ocular perfusion leading to further retinal ischemia, and this in turn induces more neovascularization. The management of NVG is very difficult thus; the conventional treatments such as antiglaucoma drugs, trabeculectomy, cyclophotocoagulation and cyclocryotherapy have poor success rates. It is very important to reduce the ischemic drive promptly for the treatment of NVG. Pan-retinal photocoagulation (PRP) is a mandatory and effective in resolving the ischemic condition and decreasing the vasoproliferative factors production.[ This management is particularly difficult in eyes with dense cataract. However, it is possible to overcome this difficulty by doing phacoemulsification and pars plana vitrectomy (PPV) + PRP. Moreover, phacoemulsification combined with PPV enables us to apply PRP from the posterior pole to the ora serrata peripherally. It has been known that Mitomycin C (MMC) increase the success rate of trabeculectomy in patients with NVG. Therefore, in the current study, we performed Intravitreal bevacizumab (IVB) injection, phacoemulsification, PPV + PRP and trabeculectomy augmented with subconjunctival injection of MMC.
The aim of this study is to evaluate safety and efficacy of this combined surgical procedure to alleviate retinal ischemia, reduce IOP, and improve visual acuity in dense cataractus NVG patients.
Subjects and Methods
Twelve eyes of 12 patients with NVG associated with dense cataract enough to obscure fundus visualization (7 males, 5 females) were included in the study in the period from July 2016 to August 2019 at Ophthalmology Department, Faculty of Medicine, Minia University. The patient's age ranged from 47 to 66 years with a mean age of 57.25 ± 5.9 years. The underlying cause for NVG was diabetes mellitus (DM) in 8 eyes (75%) and CRVO in 4 eyes (33.33%). Vitreous hemorrhage was present in half (50%) of the patients. The study was approved by the Local Ethical Review Committee and adhered to the tents of Declaration of Helsinki as well as all patients singed a written consent after discussion of the potential benefits and risks of this triple surgical procedures.
Preoperative examinations: Routine ophthalmological examinations were done after history taking including, age, sex, laterality, etiology of NVG and number of used anti-glaucoma drugs. The ocular examination includes estimation of visual acuity, IOP measurement with Goldman applanation tonometer, slit lamp examination of anterior segment, gonioscopy examination of angle of anterior chamber, biometry and ultrasonography. The demographic data were registered as in (Table 1).
Surgical procedures . In brief: - All procedures were done under peribulbar anesthesia with mild systemic sedation. IVB injection of 1.25 mg (0.05 ml) was given 2-6 days before surgery using a 27-gauge needle at the inferotemporal quadrant at 3.5-4.0 mm posterior to the limbus. Preoperative IV mannitol was given to all cases to lower IOP before surgery beside the full anti-glaucoma drugs including: topical Dorzolamide-Timolol combination, Brimonidine tartrate and oral Acetazolamide (250 mg) three times a day. Subconjunctival injection of MMC in a dose of 0.04mg/ml was done, and a period of 4 minutes was left before Conjunctival opening.
Fornix based Conjunctival incision was performed and a rectangular scleral flap of 3x4 mm was dissected. Separate temporal clear corneal incision phacoemulsification was done with intrabagal one-piece hydrophobic IOL implantation. Then, incision was closed with 10/0 nylon suture. This was followed by three ports 25-G PPV including core vitrectomy, injection of triamcinolone acetonide, induction of PVD, shaving of vitreous base, and dealing with any epiretinal membranes. PRP using diode endo-laser was done up to the far periphery (2000-3000 shots, duration 200 ms; power 400 mw). Fluid-air exchange was then performed and 20% SF6 was injected leaving 10 cc of gas to adjust pressure at the end of surgery. Then, the upper sclerotomies were sutured by vicryl 7/0 and the infusion cannula was left in place connected to the syringe of 20% SF6. Then, Healon was injected into the anterior chamber to maintain depth of anterior chamber and trabeculectomy by Kelly punch and peripheral iridectomy were done. Scleral flap was sutured by two 10/0 nylon sutures at the corners followed by watertight Conjunctival wound closure. More SF6 was injected to adjust IOP and the infusion cannula was removed, and its site was sutured with vicryl 7/0 suture. At the end of surgery, fluid was injected into the AC to test for filtration of bleb and to make sure that the conjunctiva was closed watertight. At last, triamcinolone acetonide subtenon injection was given to all eyes.
Post-operative management: The patients were prescribed prednisolone 1% (predfort, Alcon Co.) eye drops QID and tapered through 8 weeks, cyclopentolate 0.5 % TID, moxifloxacin 0.3 mg (Vigamox, Alcon Co.) eye drops QID for 2 weeks and ointment of tobramycin and dexamethasone at night for 4 weeks. Scheduled follow up visits were advised next postoperative day, one week, two weeks, monthly for three months, and then each three months for 2 years.
All patients underwent full ophthalmologic examination including BCDVA, IOP, gonioscopy, slit lamp examination, and dilated fundus examination. Antiglaucoma medications were prescribed if IOP was more than 21 mmHg. Baseline results and that of 1, 3 and 6 months, 1 and 2 years were included in the statistical analysis. This study main outcome measures were the mean BCDVA (log MAR), the mean IOP and the incidence of complications. Successful surgery was considered when the target IOP =21 mmHg was achieved without serious complications such as suprachoroidal hemorrhage, choroidal effusion, retinal detachment, endophthalmitis, phthisis bulbi, or persistent hypotony (IOP <5 mmHg). Complete success was considered when IOP of 6 -21 mmHg was achieved without any anti-glaucoma drugs, and qualified success when this target IOP was achieved with and without the use of anti-glaucoma drugs. Failure was defined as IOP >21 mmHg despite the use of maximum tolerated medications, hypotony, or the need for another glaucoma surgery.
Statistical analysis: Statistical analysis was performed with SPSS 19. Data were expressed as mean ± standard deviation (SD). Changes in the mean BCDVA and the mean IOP were compared for each follow up visit with baseline using paired t test and graphs construction done by using Graph Pad Prism 5 program. P value < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Manegment of uncontrolled NVG patients with dense cataract
| Arm | Type | Receives |
|---|---|---|
| Neovascular glaucoma | Other | Procedure: ProcedureNeovascular glaucoma patients underwent triple procedure |
Who may qualify
- Ages
- 47 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included patients with uncontrolled angle closure dense cataractus NVG with maximum tolerated anti-glaucoma medications.
Key exclusion criteria (1 listed)
- Excluded from this study eyes that had previous anti-glaucoma procedures, silicone oil filled eyes, previous buckle surgery or Conjunctival scaring from any cause, eyes with clear crystalline lens or faint cataract, eyes with corneal opacity, and eyes with visual acuity less than hand motion with good perception of light.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcedureAlso: Triple procedureTriple procedure | Procedure or surgery | Neovascular glaucoma |
Primary outcome
BCDVA
Time frame: 2 years
Best corrected distant visual acuity
IOP
Time frame: 2 years
Intra-ocular pressure
1 secondary outcome
Post-operative complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32655940Moharram HM, Abd-Elhamid Mehany Elwan S, Nassar MM, Abdelkader MF. Triple Procedure for Dense Cataractous Neovascular Glaucoma Patients. J Ophthalmol. 2020 Jun 21;2020:1251203. doi: 10.1155/2020/1251203. eCollection 2020.
- Individual participant dataSharing planned: Yes. Results of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam M Moharram, MD study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure in people with IOP Decreased and Visual Impairment, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCDVA (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.