- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07800637
Deep Sclerectomy With Scleral Bed Fenestration Versus Trabeculectomy in Medically Uncontrolled Primary Open Angle Glaucoma Patients
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Glaucoma is an optic neuropathy that is characterized by progressive structural and functional deterioration of the optic nerve (1) Glaucoma is the second leading cause of blindness worldwide, although it is the most common cause of irreversible vision loss in the whole world (2) In 2013, the number of people (aged 40-80 years) diagnosed with glaucoma worldwide was 64.3 million, increasing to 76.0 million in 2020 and expected to reach 111.8 million in 2040 (2) Primary open angle glaucoma is the commonest subtype of glaucoma. The number of persons diagnosed with POAG was estimated 52.68 million in 2020 and expected to be 79.76 million in 2040 (3).
In primary open angle glaucoma vision preservation remains the aim of treatment through correcting the only treatable risk factor in glaucoma which is the intraocular pressure. This can be achieved by different modalities including medical, laser or surgical methods (4)
In many cases medical and laser therapy can provide an effective IOP control, while surgery is still indicated when they fail to lower IOP sufficiently, or if the patient is not compliant to those methods of treatment (5).
Surgeries done for treatment of POAG are variable, including penetrating surgeries & non penetrating surgeries (6)
The example of penetrating surgeries is the trabeculectomy (both conventional or with modifications as application of mitomycin) &while examples of non-penetrating surgeries are multiple as deep sclerectomy, canaloplasty, gonioscopy-assisted transluminal trabeculotomy , goniotomy with kahook dual blade, or I stent implantation(7).
Trabeculectomy is a filtration procedure that reduces IOP by creating a connection between the anterior chamber & the subconjunctival space after excision of a part of the trabecular meshwork. Unfortunately, although it reduces IOP effectively it is associated with a higher incidence of complications as hypotony, lost anterior chamber or suprachoroidal effusion (8).
Therefore, non-penetrating glaucoma surgeries as deep sclerectomy have been developed to improve the safety of the conventional filtering procedures(9).
Deep sclerectomy prevents the sudden hypotony that occurs in penetrating surgeries by creating progressive filtration of aqueous humor without perforating the eye through the preservation of the thin trabeculo-Descemet membrane (5) Nevertheless, many authors think that deep sclerectomy is less effective than trabeculectomy for intraocular pressure reduction ,hence adding a new modification to deep sclerectomy is needed to increase its efficacy (10)
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Minya Governorate
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Minya, Minya Governorate, Egypt, 61111
- Faculty of medicine, Minia university
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients above 40 years old.
- Primary open angle glaucoma patients who are uncontrolled on maximally tolerated medical therapy.
- لاPhakic (with clear lens or visually insignificant cataract) patients
Exclusion Criteria:
- Patients with any other type of glaucoma except for primary open angle glaucoma.
- Patients who received previous laser therapy for glaucoma as laser trabeculoplasty.
- Patients with severe ocular surface diseases as ocular cicatricial pemphigoid and severe dry eye
- Previous ocular surgeries.
- Patients with significant cataract.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: deep sclerectomy with scleral bed fenestration
19 eyes of primary open angle glaucoma patients had undergone deep sclerectomy with scleral bed fenestration
|
creating fenestrations in the scleral bed
standard trabeculectomy with mitomycin c application
|
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Aktiv komparator: trabeculectomy
19 eyes of primary open angle glaucoma patients had undergone trabeculectomy surgery
|
creating fenestrations in the scleral bed
standard trabeculectomy with mitomycin c application
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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IOP
Tidsramme: 6 months
|
comparing the IOP in mmgh between the two groups after surgery
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: hosney ah zain, dectorate, Minia University Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Zhang N, Wang J, Li Y, Jiang B. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep. 2021 Jul 2;11(1):13762. doi: 10.1038/s41598-021-92971-w.
- Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.
- Oh LJ, Wong E, Lam J, Clement CI. Comparison of bleb morphology between trabeculectomy and deep sclerectomy using a clinical grading scale and anterior segment optical coherence tomography. Clin Exp Ophthalmol. 2017 Sep;45(7):701-707. doi: 10.1111/ceo.12953. Epub 2017 May 9.
- Correia Barbosa R, Goncalves R, Bastos R, Alves Pereira S, Basto R, Viana AR, Tenedorio P. Trabeculectomy Vs Non-penetrating Deep Sclerectomy for the Surgical Treatment of Open-Angle Glaucoma: A Long-Term Report of 201 Eyes. Clin Ophthalmol. 2023 Jun 6;17:1619-1627. doi: 10.2147/OPTH.S405837. eCollection 2023.
- Pantalon A, Feraru C, Tarcoveanu F, Chiselita D. Success of Primary Trabeculectomy in Advanced Open Angle Glaucoma. Clin Ophthalmol. 2021 May 27;15:2219-2229. doi: 10.2147/OPTH.S308228. eCollection 2021.
- Dada T, Sharma A, Midha N, Angmo D, Gupta S, Sihota R. Efficacy of Trabeculectomy Combined With Limited Deep Sclerectomy Versus Trabeculectomy Alone: A Randomized-controlled Trial. J Glaucoma. 2021 Dec 1;30(12):1065-1073. doi: 10.1097/IJG.0000000000001896.
- Kalala A, Gillmann K, Mermoud A. Prospective evaluation of penetrating deep sclerectomy in advanced open-angle glaucoma: Filtration surgery adapted to resource scarcity in developing countries. J Fr Ophtalmol. 2020 Mar;43(3):228-236. doi: 10.1016/j.jfo.2019.07.024. Epub 2020 Jan 24.
- Diaz-Barreda MD, Sanchez-Marin I, Boned-Murillo A, Perez-Navarro I, Martinez J, Pardina-Claver E, Perez D, Ascaso FJ, Ibanez J. Modification of Corneal Biomechanics and Intraocular Pressure Following Non-Penetrating Deep Sclerectomy. J Clin Med. 2022 Feb 24;11(5):1216. doi: 10.3390/jcm11051216.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- different glaucoma surgeries
Plan for individuelle deltakerdata (IPD)
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