This interventional trial will be conducted at the Sahiwal Teaching Hospital, Sahiwal and Ali
Fatima Teaching Hospital Lahore from March 2024 to May 2025. The study will follow the
guidelines of the Declaration of Helsinki. The study protocol will be approved by
institutional review boards of respective hospitals. Written informed consent will be taken
from all the subjects. The first subject will be recruited in March 2024 and the last subject
will be recruited in February 2025. Three more months will be required to complete the final
follow-up of the last subject.
The study will include rhegmatogenous retinal detachments patients of both sexes between 20
and 70 years of age.
Exclusion criteria will include the presence of proliferative vitreoretinopathy grade C,
previous retinal detachment surgery in the same eye, penetrating ocular trauma, intraocular
foreign bodies, and pregnant and lactating women.
A detailed history of the patients' presenting complaints, duration of symptoms, and risk
factors for retinal detachment will be gathered. Comprehensive ocular examination, including
visual acuity, intraocular pressure, and examination of the anterior and posterior segments,
will be performed. The extent of retinal detachment, location of retinal breaks, and presence
of PVR will be documented.
Sampling method will be simple random sampling. Using lottery methods patients will be
divided into two groups with 60 subjects in each group. Group 1 will be regarded as control
group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate
into one litre of BSS solution. Group 2 will be regarded as the study group and will receive
500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd
, 4th and 6th post operative weeks.
This will be a single-blind study in which the subjects will be unaware of the intervention.
Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they
are receiving.
Standard pars plana vitrectomy will be performed by two surgeons, one surgeon at Sahiwal
Teaching Hospital Sahiwal and other surgeon at Ali Fatima Teaching Hospital Lahore. Silicon
oil will be used as post operative tamponade in all subjects. A combination of steroid and
antibiotic eye drops will be administered eight times per day during the first postoperative
week. The dosing will be tapered off during the next three weeks. Patients will be instructed
to adopt the appropriate posture according to the location of retinal breaks.
Follow-up will be performed every week for three months. The development of PVR, occurrence
of retinal detachment, intraocular pressure, and visual acuity will be noted. The posterior
segment will be examined with the help of a superfield lens and wide-field contact lens for
the development of PVR and occurrence of retinal detachment.
The primary outcomes will be the development of PVR and the recurrence of retinal detachment.
All patients will be followed up until the development of one of the primary outcomes or
completion of 3 month follow, whichever occurs earlier.
Improvement in visual acuity will be secondary outcome of the study. Final visual acuity will
be measured at completion of 3 month follow up or meeting the primary outcome, whichever is
earlier.
All information will be collected using a specially designed proforma and entered into SPSS
version 26. Qualitative variables, such as sex, PVR development, recurrence of retinal
detachment, and improvement in visual acuity, will be presented as frequencies and
percentages. Quantitative variables, such as age and intraocular pressure, are presented as
mean and standard deviation.
In this prospective study we shall investigate the differences in the development of
proliferative vitreoretinopathy (PVR) between two distinct groups. Additionally, we shall
compare the difference in the occurrence of re-detachment of the retina between these groups.
Furthermore, we shall compare the improvement in visual acuity at the final follow-up visit
between the two groups. As the variables involved will be qualitative (frequency of eyes with
development of PVR, Frequency of eyes with retinal re-detachment, and frequency of eyes with
improved visual acuity), Pearson's chi-square test will be used to carry out the statistical
analysis. Statistical significance will set at P ≤ 0.05.