To research the effectiveness of traditional trabeculectomy and glaucoma drainage devices.

1)

To assess the clinical results of traditional trabeculectomy in glaucoma patients with uncontrolled primary glaucoma.

Trial design - Single Centric, hospital based cross sectional study.

This is a hospital-based study in which subjects would be recruited from the OPD of ophthalmology at Acharya Vinobha Bhave Rural Hospital Sawangi, Meghe, Wardha, Maharashtra, with clearance from the institutional ethical committee of Datta Meghe institute of higher education and research and will adhere to the principles of the Helsinki Declaration. The specifics of the surgery will be properly explained to each patient. The study will gradually recruit the patients who meet the inclusion criteria. This study will be carried out under standard preoperative, intraoperative and post operative conditions by a single experienced surgeon. Study participants will be divided into two groups. Group-A (Trabeculectomy group) and Group-B (Glaucoma Drainage Device group) taking into consideration factors such as staphyloma, scleral thinning and high myopia, participants with this pathology will be undergoing glaucoma drainage device implantation. Subjects will be invited & screened for inclusion and exclusion criteria for selection. All patients in both groups will be followed up on a monthly basis for the next two years. At each follow-up, we evaluate IOP, visual acuity and need of anti-glaucoma medications in post-operative patients, and both groups are compared.

1)

Patients with uncontrolled primary glaucoma.

1)

Patients with any ocular infection.

There will be a clinical history gathered and best corrected visual acuity (Snellen’s chart), slit lamp examination, Intra Ocular Pressure measurement (applanation tonometer), fundoscopy (slit lamp biomicroscopy with 90 D, direct, and indirect ophthalmoscopy with 20 D) and gonioscopy are all included in a thorough ophthalmic checkup. OCT-RNFL and Perimetry will be done. Patients who underwent trabeculectomy and glaucoma drainage device surgery (Aurolab aqueous drainage implant) will be included in the study.

A conjunctival flap precisely fornix based will be made, and the corneal traction suture will be positioned at the 12 o’clock position. Gentle diathermy will be used to cauterise the blood vessels. A rectangular scleral flap of 4×3 mm with partial thickness will be made and a trab of 0.8×2.0 mm will be achieved followed by a Peripheral Iridectomy. A single 10-0 nylon suture will be given to secure the scleral flap, with possible extra sutures in between the sutures and at the flap’s corners. The conjunctiva at the limbus will be stitched up with a 10-0 nylon suture.

Tenon’s tissue will be dissected after a conjunctival flap (fornix based). The operating surgeon will choose the implant insertion site depending on the amount of conjunctival scarring, if any, and whether it will be supero-temporal or infero-nasal. Using muscle hooks, adjoining recti muscles in the desired quadrant will be isolated. After that, the AADI implant will be prepped to look for possible manufacturing flaws. The end plate will then be positioned so that the front edge of the plate will be roughly 8 mm away from the limbus, in between the neighbouring recti muscles. After that, 9-0 Nylon sutures will be used to secure the plate to the underlying sclera by passing them through the implant’s fixation holes. The tube’s connection to the sclera will be stabilised using a non-compressing mattress suture. By tying it with a 6-0 vicryl suture, temporary tube occlusion will be accomplished. A 23-gauge needle will be used to produce a scleral fistula at a distance of roughly 3 mm from the limbus. In order for the tube to lie 1-2 mm past the surgical limbus, it will then be anteriorly bevelled up and introduced into the AC through the scleral tract. The operating surgeon will directly observe the tube to ensure its place. Fenestrations in the tube will be constructed, necessitating short-term IOP management in the immediate postoperative period until the vicryl suture lyses. After that, 8-0 Vicryl sutures will be used to close the conjunctiva and tenon’s capsule using both interrupted and running procedures.

Primary outcome measures 1)

Visual acuity testing by Snellen’s chart:

It is used to assess distant visual acuity. The patient is seated 6m away from the Snellen’s chart and is instructed to read the chart with both eyes, one after the other. When the patient can read up to a 6 m line, his visual acuity is reported as 6/6, and depending on the smallest line that the patient can read from a 6 m distance, his vision is recorded as 6/9, 6/12, 6/18, 6/24, 6/36, and 6/60.

Secondary outcome measures 1)

Moorfields bleb grading ( Figure 1):

The bleb is assessed and characterized with respect to: •

Diffusion area

Using sample size formula with desired error of margin n = Z 2 α / 2 ∗ P ∗ 1 − P d 2

Where Zα/2 is the level of significance at 5% i.e.:

99.5% confidence interval = 2.8

P = Prevalence of secondary glaucoma = 0.50% i.e. 0.005

d = Desired error of margin = 5% = 0.05 n = 2.8 2 × 0.005 × 1 − 0.005 0.05 2

n = 14.8

n = 15 patient needed in each group.

Total sample size = 30

Study reference: Arun Narayanaswamy et al. ¹³

Formula reference: Daniel et al. ¹⁴

Sample size: After meeting the inclusion and exclusion requirements, a total of 30 SUBJECTS will be registered in this interventional cross-sectional hospital-based study.

This will be done with the aid of descriptive and inferential statistics, chi-square tests, odds ratios, and software analysis with the SPSS-24.0 system and Graph Pad prism 7.0 version and p < 0.05 is considered as level of significance.

We plan to publish in an indexed journal and present the study in national conference proceedings.

The recruitment of participants has been started.

Institutional Ethical Clearance has been obtained on 29/8/2022

IEC No – DMIMS (DU)/IEC/2022/198

CTRI Registration was done on 26/07/2023

CTRI Number – REF/2023/07/070943